Recall Z-1650-2021— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2021-04-07, terminated 2024-08-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.. Reason: The device may contain a manufacturing defect of a missing resistance spot weld (RSW)..
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-07
- Terminated
- 2024-08-23
- Firm location
- Mounds View, MN, United States
Product description
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
Reason for recall
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
Data sourced from openFDA. This site is unofficial and independent of the FDA.