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  • Device 1
  • Manufacturer 1
  • Event 124969
  • Implant 0
Field Safety Notices about SynchroMed II Programmable Pump
  • Type of Event
    Field Safety Notice
  • Event Number
    2016031832
  • Date
    2016-03-11
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/03/synchromed-ii-programmable-pump/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about Medtronic DLP Femoral Arterial Cannula, Femoral Cannula and Insertion ...
  • Type of Event
    Field Safety Notice
  • Event Number
    2015062281
  • Date
    2015-06-16
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2015/06/medtronic-dlp-femoral-aterial-cannula,-femoral-cannula-and-insertion-kits/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about Bio-Cal Temperature Controller
  • Type of Event
    Field Safety Notice
  • Event Number
    2018022169
  • Date
    2018-02-14
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2018/02/bio-cal-temperature-controller/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about MyCareLink Patient Monitor
  • Type of Event
    Field Safety Notice
  • Event Number
    2016060601
  • Date
    2016-06-05
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/06/mycarelink-patient-monitor/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about EnTrust® and Escudo® VR/DR/AT ICDs
  • Type of Event
    Field Safety Notice
  • Event Number
    2018064554
  • Date
    2018-06-29
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2018/06/entrust-and-escudo-vrdrat-icds/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about Reveal LINQ Insertable Cardiac Monitor (ICM)
  • Type of Event
    Field Safety Notice
  • Event Number
    2016030740
  • Date
    2016-03-04
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/03/reveal-linq-insertable-cardiac-monitor-icm/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about Medtronic® DLP® Single Stage Venous Cannula with Metal Tip
  • Type of Event
    Field Safety Notice
  • Event Number
    2013024430
  • Date
    2013-02-22
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2013/medtronic-dlp-single-stage-venous-cannula-with-metal-tip/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about Medtronic CareLink Monitor (Patient Home Monitor)
  • Type of Event
    Field Safety Notice
  • Event Number
    2016041145
  • Date
    2016-04-12
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/04/medtronic-carelink-monitor-patient-home-monitor/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about Medtronic Spinal Cord Stimulation (SCS) Therapy
  • Type of Event
    Field Safety Notice
  • Event Number
    2014022232
  • Date
    2014-02-18
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2014/medtronic-spinal-cord-stimulation-scs-therapy/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about 1x4 DBS Restore Adaptor and 2x4 DBS Restore Adaptor
  • Type of Event
    Field Safety Notice
  • Event Number
    2016063799
  • Date
    2016-06-24
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/06/1x4-dbs-restore-adaptor-and-2x4-dbs-restore-adaptor/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about specify™ 5-6-5 surgical lead and specify™ 2x8 surgical lead
  • Type of Event
    Field Safety Notice
  • Event Number
    2016020957
  • Date
    2016-02-05
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/02/specify-5-6-5-surgical-lead-og-specify-2x8-surgical-lead/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about SynchroMed® II Implantable Drug Pumps
  • Type of Event
    Field Safety Notice
  • Event Number
    2016103670
  • Date
    2016-10-25
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/10/synchromed-ii-implantable-drug-pumps/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about Sutureless Connector (SC) Intrathecal Catheters
  • Type of Event
    Field Safety Notice
  • Event Number
    2013060547
  • Date
    2013-06-06
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2013/sutureless-connector-sc-intrathecal-catheters/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about Cougar, Zinger, Thunder & ProVia
  • Type of Event
    Field Safety Notice
  • Event Number
    2013110395
  • Date
    2013-11-05
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2013/cougar,-zinger,-thunder-provia/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about MiniMed™ remote controller (MMT-500 or MMT-503)
  • Type of Event
    Field Safety Notice
  • Event Number
    2018081666
  • Date
    2018-08-13
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2018/08/minimed-remote-controller-mmt-500-or-mmt-503/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about Guardian™ Connect Mobile App
  • Type of Event
    Field Safety Notice
  • Event Number
    2018071743
  • Date
    2018-07-12
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2018/07/guardian-connect-mobile-app/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about Paradigm Insulin Infusion sets
  • Type of Event
    Field Safety Notice
  • Event Number
    2013062061
  • Date
    2013-06-18
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2013/paradigm-insulin-infusion-sets/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about CareLink™ iPro™ Therapy Management Software
  • Type of Event
    Field Safety Notice
  • Event Number
    2017112865
  • Date
    2017-11-19
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2017/11/carelink-ipro-therapy-management-software/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about Paradigm reservoir models MMT-326A & MMT-332A
  • Type of Event
    Field Safety Notice
  • Event Number
    2013070093
  • Date
    2013-07-02
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2013/paradigm-reservoir-models-mmt-326a-mmt-332a-information-til-brugere/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about Paradigm reservoir models MMT-326A & MMT-332A
  • Type of Event
    Field Safety Notice
  • Event Number
    2013070093
  • Date
    2013-07-02
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2013/paradigm-reservoir-models-mmt-326a-mmt-332a-information-til-sundhedsprofessionelle/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about MiniMed 640G Insulin Pump
  • Type of Event
    Field Safety Notice
  • Event Number
    2017020857
  • Date
    2017-02-07
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2017/02/minimed-640g-insulin-pump/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about MiniMed 640G
  • Type of Event
    Field Safety Notice
  • Event Number
    2015094807
  • Date
    2015-09-30
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2015/09/minimed-640g/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about Solera Screwdrivers
  • Type of Event
    Field Safety Notice
  • Event Number
    2015093976
  • Date
    2015-09-25
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2015/09/solera-screwdrivers/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about O-arm® 1000 Surgical Imaging System
  • Type of Event
    Field Safety Notice
  • Event Number
    2018093579
  • Date
    2018-09-26
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2018/09/o-arm-1000-surgical-imaging-system-/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
Field Safety Notices about O-armTM O2 Imaging System
  • Type of Event
    Field Safety Notice
  • Event Number
    2018104791
  • Date
    2018-10-31
  • Event Country
    Denmark
  • Event Source
    DMA
  • Event Source URL
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2018/10/o-armtm-o2-imaging-system/
  • Notes / Alerts
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Denmark.
  • Extra notes in the data
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About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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