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  • Device 27
  • Manufacturer 92
  • Event 253
  • Implant 4
Device Recall St. Jude Medical CPS Slitter
  • Model / Serial
    All lots with a manufacturing date of May 30, 2006 or earlier
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Hospitals/Medical Centers in AZ, CA, MS, NY, & PA
  • Product Description
    CPS Slitter, Model 410191
  • Manufacturer
    St Jude Medical CRMD
  • 1 Event
    • Recall of Device Recall St. Jude Medical CPS Slitter
Device Recall St. Jude Medical CPS Valve Bypass Tool (VBT)
  • Model / Serial
    All lots with a manufacturing date of May 30, 2006 or earlier
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Hospitals/Medical Centers in AZ, CA, MS, NY, & PA
  • Product Description
    CPS Valve Bypass Tool (VBT), Model 410192
  • Manufacturer
    St Jude Medical CRMD
  • 1 Event
    • Recall of Device Recall St. Jude Medical CPS Valve Bypass Tool (VBT)
Device Recall St. Jude Medical CPS Direct SL
  • Model / Serial
    All lots with a manufacturing date of May 30, 2006 or earlier
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Hospitals/Medical Centers in AZ, CA, MS, NY, & PA
  • Product Description
    CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120, 410121, 410122, 410123, 410124, 410125, & 410126
  • Manufacturer
    St Jude Medical CRMD
  • 1 Event
    • Recall of Device Recall St. Jude Medical CPS Direct SL
Device Recall St. Jude Medical CPS Aim
  • Model / Serial
    All lots with a manufacturing date of May 30, 2006 or earlier
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Hospitals/Medical Centers in AZ, CA, MS, NY, & PA
  • Product Description
    CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148
  • Manufacturer
    St Jude Medical CRMD
  • 1 Event
    • Recall of Device Recall St. Jude Medical CPS Aim
Device Recall St. Jude Medical CPS Implant Kit
  • Model / Serial
    All lots with a manufacturing date of May 30, 2006 or earlier
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Hospitals/Medical Centers in AZ, CA, MS, NY, & PA
  • Product Description
    CPS Implant Kit, Model 410190
  • Manufacturer
    St Jude Medical CRMD
  • 1 Event
    • Recall of Device Recall St. Jude Medical CPS Implant Kit
"Left Ventricular Electrodes for QuickSite® CRT", Models 1056T and 1058T and "Left Ventricular El...
  • Model / Serial
  • Manufacturer
    St. Jude Medical CRMD
  • 1 Event
    • Recall Or Safety Alert for "Left Ventricular Electrodes for QuickSite® CRT", Models 1056T and 1058T and "Left Ventricular Electrodes for QuickFlex® TRC", Models 1156T and 1158T manufactured by St. Jude Medical CRMD, USA.
Implantable pulse generators: "Eon", Model 65-3716 and "Eon Mini", Model 65-3788 for stimulation ...
  • Model / Serial
  • Manufacturer
    St. Jude Medical
  • 1 Event
    • Recall Or Safety Alert for Implantable pulse generators: "Eon", Model 65-3716 and "Eon Mini", Model 65-3788 for stimulation of the spinal cord and "Brio", Model 65-6788 for deep brain stimulation, manufactured by St. Jude Medical USA
Implantable pulse generators: "Eon MiniTM", Model 65-3788 for stimulation of the spinal cord and ...
  • Model / Serial
  • Manufacturer
    St. Jude Medical
  • 1 Event
    • Recall Or Safety Alert for Implantable pulse generators: "Eon MiniTM", Model 65-3788 for stimulation of the spinal cord and "BrioTM", Model 65-6788 for deep brain stimulation. Serial numbers manufactured before September 2010 by St. Jude Medical USA
Implantable Pulse Generator (GPI) "Eon MiniTM" Model 65-3788 for stimulation of the spinal cord, ...
  • Model / Serial
  • Manufacturer
    St. Jude Medical
  • 1 Event
    • Recall Or Safety Alert for Implantable Pulse Generator (GPI) "Eon MiniTM" Model 65-3788 for stimulation of the spinal cord, Eon Min Model 3721 Charger and Eon Mini Model 3719 Charger Accessory, manufactured by St. Jude Medical USA
Fortified ™ Implantable Cardioverter Defibrillators, FortifyAssura ™, QuadraAssura ™, QuadraAssur...
  • Model / Serial
  • Manufacturer
    St. Jude Medical
  • 1 Event
    • Recall Or Safety Alert for Fortified ™ Implantable Cardioverter Defibrillators, FortifyAssura ™, QuadraAssura ™, QuadraAssura MP ™, Unify ™, UnifyAssura ™ and UnifyQuadra ™, manufactured by St. Jude Medical, USA, between January 2010 and May 2015.
8-Channel Lead for the St. Jude Medical Infinity™ DBS (Deep Brain Stimulation) System
  • Model / Serial
    Model No.: 6172ANS, 6170ANS Multiple batch & serial numbers (See attached FSN) UDI: 05415067020635, 05415067030306, 05415067020680, 05415067030320
  • Product Description
    Implantable Pulse Generators
  • Manufacturer
    St. Jude Medical Inc.
  • 1 Event
    • translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice
1. Merlin PCS 3650 Software Upgrade Kit , 2. Merlin@home Transmitter Software, 3. High Voltage ...
  • Model / Serial
  • Product Description
    1. Merlin PCS 3650 Software Upgrade Kit , 2. Merlin@home Transmitter Software, 3. High Voltage Device ICD and CRT-D (model name Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, Unify Quadra™, Promote Quadra™ and Ellipse™), St. Jude Medical, Cardiac Rhythm Management Division
  • Manufacturer
    St Jude Medical (Singapore) Pte Ltd
  • 1 Event
    • Field Safety Notices about 1. Merlin PCS 3650 Software Upgrade Kit , 2. Merlin@home Transmitter Software, 3. High Voltage Device ICD and CRT-D (model name Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, Unify Quadra™, Promote Quadra™ and Ellipse™), St. Jude Medical
Merlin PCS 3650 Software Upgrade Kit, St. Jude Medical
  • Model / Serial
  • Product Description
    Merlin PCS 3650 Software Upgrade Kit, St. Jude Medical, Cardiac Rhythm Management Division
  • Manufacturer
    St. Jude Medical (Singapore) Pte Ltd
  • 2 Events
    • Field Safety Notices about Merlin PCS 3650 Software Upgrade Kit, St. Jude Medical
    • Field Safety Notices about Merlin PCS 3650 Software Upgrade Kit, St. Jude Medical
St. Jude Medical AGILIS Steerable Catheter Introducer
  • Model / Serial
    Lot number range: 1169725 to 1181488 EXPANDED RECALL additional lot numbers are: 1182741, 1182742, 1182743, 1182744, 1182745, 1184211, 1185314, 1186554, 1186557.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide- USA states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV. ---Foreign includes: Austria, Belgium, Denmark, France, Germany, Great Britain, Italy, Lichtenstein, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom
  • Product Description
    St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308 (Australia). Sterile EO. St. Jude Medical Daig Division, Inc., Minnetonka, MN 55345-2126 USA. This St. Jude Medical (SJM) Agilis Steerable Catheter Introducer Set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise >than or equal to 180-degrees and counter-clockwise >than or equal to 90-degrees. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization. EXPANDED RECALL The Reorder number affected by the recall expansion is 408304.
  • Manufacturer
    St. Jude Medical / Daig Division
  • 1 Event
    • Recall of St. Jude Medical AGILIS Steerable Catheter Introducer
St. Jude Medical FASTCATH Hemostasis Introducer
  • Model / Serial
    Lot Number: 6372
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (CA, MI, PA and TN), China and Belgium.
  • Product Description
    St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Max. Guidewire O.D. .038", 2010-01, Manufacturer, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO. || Used for the introduction of catheters into a vessel.
  • Manufacturer
    St. Jude Medical
  • 1 Event
    • Recall of St. Jude Medical FASTCATH Hemostasis Introducer
St. Jude Medical FASTCATH Hemostasis Introducer
  • Model / Serial
    Lot Number: 4219
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (CA, MI, PA and TN), China and Belgium.
  • Product Description
    St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM, Lot 4219 Max. Guidewire O.D. .038", 2010-01, Manufacture, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO. || Used for the introduction of catheters into a vessel.
  • Manufacturer
    St. Jude Medical
  • 1 Event
    • Recall of St. Jude Medical FASTCATH Hemostasis Introducer
Device Recall Heritage Labs St. Jude Childhood Cancer Study kit
  • Model / Serial
    All kits containing Triad alcohol prep pads
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Germany
  • Product Description
    Heritage Labs St. Jude Childhood Cancer Study Kit, Product A1185. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0 and blood specimen collection supplies. || Blood specimen collection
  • Manufacturer
    Heritage Labs International LLC
  • 1 Event
    • Recall of Device Recall Heritage Labs St. Jude Childhood Cancer Study kit
All models of RF enabled St. Jude Medical Ellipse™, Fortify Assura™, Unify Assura™, and Quadra As...
  • Model / Serial
  • Product Description
    St. Jude Medical: All models of RF enabled St. Jude Medical Ellipse™, Fortify Assura™, Unify Assura™, and Quadra Assura™ implantable cardioverter defibrillators (ICDs) and Assurity™ and Allure™ pacemakers when used with Merlin@home™ RF Remote Monitoring Transmitter Model EX1150.
  • Manufacturer
    St. Jude Medical
  • 1 Event
    • Safety Alert Or Field Safety Notices for All models of RF enabled St. Jude Medical Ellipse™, Fortify Assura™, Unify Assura™, and Quadra Assura™ implantable cardioverter defibrillators (ICDs) and Assurity™ and Allure™ pacemakers when used with Merlin@home™ RF Remote Monitoring Transmitter Model EX1150.
St. Jude Medical Infinity™ DBS System (8-Channel)
  • Model / Serial
  • Product Description
    St. Jude Medical (Abbott): St. Jude Medical Infinity™ DBS System (8-Channel)
  • Manufacturer
    St. Jude Medical (Abbott)
  • 2 Events
    • Safety Alert Or Field Safety Notices for St. Jude Medical Infinity™ DBS System (8-Channel)
    • Safety Alert Or Field Safety Notices for St. Jude Medical Infinity™ DBS System (8-Channel)
Device Recall St. Jude Medical, Model 3085, DualChamber External Pulse Generator
  • Model / Serial
    S/N 0311030, 0323107, 0912101 & 0912110 (total = 12)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: USA including states of CA & FL
  • Product Description
    St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator || The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203H / Model 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.
  • Manufacturer
    Osypka Medical Inc
  • 1 Event
    • Recall of Device Recall St. Jude Medical, Model 3085, DualChamber External Pulse Generator
Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 1...
  • Model / Serial
    Lot 1164732
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, FL, KY, IL, MN, NY, OH, TN, VA & WI
  • Product Description
    Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Single use. St. Jude medical, DAIG Division, Inc., Minnetonka, MN 55345-2126 USA
  • Manufacturer
    St. Jude Medical / Daig Division
  • 1 Event
    • Recall of Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Single use. St. Jude medical, DAIG Division, Inc., Minnetonka, MN 55345-2126 USA
All models of RF enabled St. Jude Medical Ellipse™ and other devices
  • Model / Serial
  • Manufacturer
    St. Jude Medical
  • 1 Event
    • Field Safety Notices about All models of RF enabled St. Jude Medical Ellipse™ and other devices
Implantable Cardioverter Defibrillator: St. Jude Medical Fortify™, Fortify Assura™, Quadra Assura...
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Implantable Cardioverter Defibrillator: St. Jude Medical Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™. Priority 1 – For Immediate Action
  • Manufacturer
    St. Jude Medical, Inc.
  • 1 Event
    • Field Safety Notices about Implantable Cardioverter Defibrillator: St. Jude Medical Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™
St. Jude Medical ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programme...
  • Model / Serial
    St. Jude Medical ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programmer software version 17.2.2 rev. 0Affected ICD/CRT-D devices: Current/Promote/AnalyST, Unify/Fortify, Assura and Ellipse families Multiple ARTG numbers for ICD/CRT-D devicesARTG number for the Merlin Programmer: 124262
  • Manufacturer
    St Jude Medical Australia Pty Ltd
  • 1 Event
    • Recall of St. Jude Medical ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programmer software version 17.2.2 rev. 0 Affected ICD/CRT-D devices: Current/Promote/AnalyST, Unify/Fortify, Assura and Ellipse families
St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs)
  • Model / Serial
    St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs)Models: CD1277 (-36 and -36Q) , CD1377 (-36, -36Q, -36C and -36QC), CD2277 (-36 and -36Q), CD2377 (-36, -36Q, -36C and -36QC) Serial Numbers: beginning with “1” that are below 1132470, beginning with the number “7” that are below 7126267 and all serial numbers beginning with an “8” are affected.ARTG Numbers: 207181, 207182, 207183, 207184, 207185, 207186, 207187, 207189, 202934, 202938, 198821, 198822
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    St Jude Medical Australia Pty Ltd
  • 1 Event
    • Recall of St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs)
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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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