Biotronik ILIVIA 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik Inc is recalling 1,547 ILIVIA 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a life-sustaining medical device (ICD/CRT-D) with a potential for premature battery depletion, which poses a risk of harm if the device fails to treat life-threatening arrhythmias, but no specific injuries or deaths are reported in the source text.
Plain-English summary
Biotronik Inc is recalling 1,547 units of the ILIVIA 7, DR-T DF-1 PROMRI implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The recall is issued because there is a potential for premature battery depletion in these devices.
The affected devices are intended to provide ventricular tachycardia pacing and ventricular defibrillation for the automatic treatment of life-threatening ventricular arrhythmias. The recall covers units distributed nationwide in the United States and worldwide.
Patients with these implanted devices should contact their healthcare provider for evaluation and appropriate management. The recall is classified as Class II by the FDA.
The recalled product
- Product
- BIOTRONIK ILIVIA 7, DR-T DF-1 PROMRI, REF 404622, UDI: 04035479142094 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 1,547
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by BIOTRONIK Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 25 products in this recall →Related recalls
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