Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik Inc is recalling 658 ITREVIA 7 implantable defibrillators due to a potential for premature battery depletion.
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 (ICD/CRT-D) where premature battery depletion poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Biotronik Inc is recalling 658 units of the ITREVIA 7, DR-T QP DF-1 implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D). The recall is due to a potential for premature battery depletion in these devices.
The affected devices are intended to provide ventricular tachycardia pacing and ventricular defibrillation for the automatic treatment of life-threatening ventricular arrhythmias. The recall covers units distributed nationwide in the United States and worldwide.
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 recalled product
- Product
- BIOTRONIK ITREVIA 7, DR-T QP DF-1, REF 392412, UDI: 04035479128807 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 658
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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