Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik is recalling 499 ITREVIA 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 involves a life-sustaining medical device with a potential for premature battery depletion, which poses a risk of harm if the device fails to treat life-threatening arrhythmias. No injuries or illnesses are reported in the source text, placing this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biotronik Inc is recalling 499 units of the ITREVIA 7, VR-T DF-1 Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D). The recall is issued because there is a potential for premature battery depletion in these devices. The affected products are identified by Reference 393040 and UDI 04035479129552.
The affected devices are distributed nationwide in the United States and worldwide. The recall covers specific serial numbers listed in the agency's official record. These devices are intended to provide ventricular tachycardia pacing and ventricular defibrillation for the automatic treatment of life-threatening ventricular arrhythmias.
Patients with these devices should contact their healthcare provider or Biotronik Inc to determine if their specific device is affected and to discuss appropriate clinical management. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 499
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 ILIVIA Neo 7 VR-T DF-1 ProMRI Recall 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
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