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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 92 Results
PMA Number: P010031
 
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Medtronic RV Lead Integrity Alert , Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154... 3 04/08/2009 Medtronic Inc. Cardiac Rhythm Managment
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) 2 07/28/2022 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobal... 2 06/14/2022 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Med... 2 11/24/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization T... 2 05/20/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrh... 2 05/04/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P d... 2 05/04/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia.... 2 05/04/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Addi... 2 05/04/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defib... 2 01/26/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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