Biotronik ILIVIA 7 ICDs Recalled for Premature Battery Depletion
Biotronik is recalling 914 ILIVIA 7 ICDs due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
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 Class II medical device with a risk of harm (premature battery depletion in a life-sustaining device) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Biotronik Inc is recalling 914 units of the ILIVIA 7, VR-T DF-1 ProMRI Implantable Cardioverter Defibrillator (ICD). The recall is issued because there is a potential for premature battery depletion in these devices. The product is intended to provide ventricular tachycardia pacing and ventricular defibrillation for the automatic treatment of life-threatening ventricular arrhythmias.
The affected devices have been distributed nationwide in the United States and worldwide. The recall number is Z-1457-2021. Specific serial numbers for the affected units are listed in the official recall documentation.
Patients with these devices should contact their healthcare provider or Biotronik Inc for further instructions regarding the recall and potential replacement or repair.
The recalled product
- 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.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 914
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
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- HighBiotronik ILIVIA Neo 7 VR-T DF-1 ProMRI Recall for Battery Depletion
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- 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
Same hazard · battery depletion
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FDA (Devices) · 2025-10-08
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- ModerateAllura Xper CV20 X-ray systems recalled after BIOS battery halts startup
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- ModerateAllura Xper FD20/15 OR Table systems recalled over BIOS battery depletion
FDA (Devices) · 2025-10-08
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