Recall Z-1457-2021— BIOTRONIK Inc
Class II · Terminated
Class II FDA medical device recall by BIOTRONIK Inc, initiated 2021-03-08, terminated 2023-04-25. FDA's recall record names no specific 510(k) clearance for this event. Product: BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.. Reason: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds).
- Recalling firm
- BIOTRONIK Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-08
- Terminated
- 2023-04-25
- Firm location
- Lake Oswego, OR, United States
Product description
BIOTRONIK ILIVIA 7, VR-T DF-1 ProMRI, REF 404625, UDI: 04035479142124 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Reason for recall
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Data sourced from openFDA. This site is unofficial and independent of the FDA.