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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 27 Results
PMA Number: P010031
 
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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)
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viv... 1 03/27/2021 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)
Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillato... 2 01/26/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardio... 2 01/26/2021 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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