Biotronik ILIVIA 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik is recalling 779 ILIVIA 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 (ICD/CRT-D) with a defect (premature battery depletion) that poses a risk of harm if the device fails to treat life-threatening arrhythmias, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Biotronik Inc is recalling 779 units of the ILIVIA 7, VR-T DF4 ProMRI 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 product is identified by Reference 404626 and UDI 04035479142131.
The 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. A list of specific serial numbers for the 779 affected units is available in the recall documentation.
Patients with these implanted devices should contact their healthcare provider or Biotronik Inc to discuss the recall and determine the appropriate course of action. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 779
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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