International Medical Devices Database

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

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Type of Event
Field Safety Notice
Event ID
6.6.4-2014-12943
Event Country
Sweden
Event Source
SMPA
Event Source URL
https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2014/Engangsprodukter--LUTONIX-014-och-035-OTW-Drogbelagd-PTA-Dilatationskateter--Lutonix-Inc/#
Notes / Alerts

Swedish data is current through 2018. All of the data comes from the Swedish Medical Products 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 Sweden.
Extra notes in the data

FA2014-02
Action
Products should be revoked.

Device

LUTONIX 014 and 035 OTW Drug Coated PTA dilatation catheter

Model / Serial
Product Description
Disposable products
Manufacturer
Lutonix Inc.

Manufacturer

Lutonix Inc.

Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
SMPA

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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Disclaimer

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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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Field Safety Notices about LUTONIX 014 and 035 OTW Drug Coated PTA dilatation catheter

What is this?

Device

LUTONIX 014 and 035 OTW Drug Coated PTA dilatation catheter

Manufacturer

Lutonix Inc.