Biotronik Inventa 7 ICDs Recalled for Premature Battery Depletion
Biotronik is recalling 702 Inventa 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 is classified as FDA Class II. The hazard involves a life-sustaining medical device (ICD) with a potential for premature battery depletion, which poses a risk of harm if the device fails to treat life-threatening arrhythmias, although no injuries or deaths are reported in the source text.
Plain-English summary
Biotronik Inc is recalling 702 units of the Biotronik Inventa 7, HF-T QP DF4 IS4 (REF 393012) Implantable Cardioverter Defibrillators (ICDs). The recall is due to a potential for premature battery depletion in these devices. The affected units are distributed nationwide in the United States and worldwide.
The Inventa 7 ICD is intended to provide ventricular tachycardia pacing and ventricular defibrillation for the automatic treatment of life-threatening ventricular arrhythmias. The recall covers specific serial numbers listed in the agency's official documentation. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Patients with these specific devices should contact their healthcare provider or Biotronik Inc to determine if their device is affected and to discuss appropriate monitoring or replacement options. The recall is classified as Class II by the FDA.
The recalled product
- Product
- BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 702
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
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