Biotronik ILIVIA 7 ICD Recall for Premature Battery Depletion
Biotronik is recalling 3,497 ILIVIA 7 implantable cardioverter defibrillators due to a potential for premature battery depletion. The recall covers units 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) with a defect (premature battery depletion) that poses a risk of harm if the device fails to treat life-threatening arrhythmias, but no specific injuries or deaths are reported in the source text.
Plain-English summary
Biotronik Inc is recalling 3,497 units of the ILIVIA 7, DR-T DF4 ProMRI implantable cardioverter defibrillator (ICD). The recall is issued because there is a potential for premature battery depletion in these devices. The affected product is 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. The specific serial numbers for the affected devices are listed in the official recall documentation. Biotronik Inc is the recalling firm and manufacturer.
Patients with these devices should contact their healthcare provider or Biotronik for instructions on monitoring the device battery status and potential replacement.
The recalled product
- Product
- BIOTRONIK ILIVIA 7, DR-T DF4 ProMRI, REF 404623, UDI: 04035479142100 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 3,497
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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