Biotronik Inventa 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik Inc is recalling 285 Inventa 7 defibrillators 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). Premature battery depletion in a life-saving defibrillator is a significant functional defect.
Plain-English summary
Biotronik Inc is recalling 285 units of the BIOTRONIK INVENTRA 7, VR-T DX DF-1 implantable cardioverter defibrillators. 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 are distributed nationwide in the United States and worldwide. The recall includes specific serial numbers listed in the official FDA record Z-1460-2021. The agency has classified this recall as Class II.
Patients with these devices should contact their healthcare provider or Biotronik Inc for further instructions regarding the potential battery issue.
The recalled product
- Product
- BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 285
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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