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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Same manufacturer · BIOTRONIK Inc
See all →- HighBiotronik Inventa 7 ICDs Recalled for Premature Battery Depletion
FDA (Devices) · 2021-04-28
- SevereBIOTRONIK Ilestro 7 VR-T DX Defibrillators Recalled for Battery Depletion
FDA (Devices) · 2021-04-28
- HighBiotronik Intica Neo 7 VR-T DX DF-1 ProMRI Recall for Battery Depletion
FDA (Devices) · 2021-04-28
- SevereBiotronik Inventa 7 Defibrillators Recalled for Premature Battery Depletion
FDA (Devices) · 2021-04-28
- HighBiotronik ILIVIA 7 ICD Recall for Premature Battery Depletion
FDA (Devices) · 2021-04-28
Same hazard · battery depletion
See all →- ModerateAllura Xper FD20 OR Table systems recalled over BIOS battery depletion
FDA (Devices) · 2025-10-08
- ModerateAllura Xper FD10/10 X-ray systems recalled for BIOS battery startup failure
FDA (Devices) · 2025-10-08
- ModerateAllura Xper FD20/20 X-ray systems recalled for BIOS battery startup failure
FDA (Devices) · 2025-10-08
- ModerateAllura Xper CV20 X-ray systems recalled after BIOS battery halts startup
FDA (Devices) · 2025-10-08
- ModerateAllura Xper FD20/15 OR Table systems recalled over BIOS battery depletion
FDA (Devices) · 2025-10-08
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