Biotronik ILIVIA NEO 7 DR-T DF-1 ProMRI Defibrillators Recalled for Battery Depletion
Biotronik is recalling 98 ILIVIA NEO 7 DR-T DF-1 ProMRI 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) with a potential for premature battery depletion, which poses a risk of harm if the device fails to treat life-threatening arrhythmias, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biotronik Inc is recalling 98 units of the ILIVIA NEO 7 DR-T DF-1 ProMRI Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D). The recall is being conducted because there is 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. The specific serial numbers affected are listed in the structured product information.
Consumers and healthcare providers should contact Biotronik Inc for further instructions regarding the recall and potential replacement or repair of the devices.
The recalled product
- Product
- BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 98
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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