Biotronik ITREVIA 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik is recalling 386 ITREVIA 7 implantable defibrillators due to a potential for premature battery depletion.
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 high-risk medical device (ICD) with a potential for failure (premature battery depletion) that could lead to serious harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biotronik Inc is recalling 386 units of the ITREVIA 7, VR-T DX 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 the 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 management options.
The recalled product
- Product
- BIOTRONIK ITREVIA 7, VR-T DX DF-1, REF 393037, UDI: 04035479129521 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 386
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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