Biotronik ILIVIA Neo 7 VR-T DF-1 ProMRI Recall for Battery Depletion
Biotronik is recalling 74 ILIVIA Neo 7 VR-T DF-1 ProMRI implantable cardioverter defibrillators due to a potential for premature battery depletion.
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 involves a risk-of-harm medical device (premature battery depletion in a life-saving device) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Biotronik Inc is recalling 74 units of the ILIVIA Neo 7 VR-T DF-1 ProMRI implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D). The device is intended to provide ventricular tachycardia pacing and ventricular defibrillation for the automatic treatment of life-threatening ventricular arrhythmias.
The recall is being conducted because there is a potential for premature battery depletion in these devices. The affected units are identified by specific serial numbers listed in the recall documentation.
The recall covers distribution in the United States and worldwide. Consumers and healthcare providers should contact Biotronik Inc or their medical device representative for further instructions regarding the affected devices.
The recalled product
- Product
- BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Hazard
- Affected units
- 74
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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