BIOTRONIK Ilestro 7 DR-T ICDs Recalled for Premature Battery Depletion
BIOTRONIK Inc is recalling Ilestro 7 DR-T implantable cardioverter 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) with a defect (premature battery depletion) that 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 where injury has not yet been reported.
Plain-English summary
BIOTRONIK Inc is recalling specific units of the Ilestro 7 DR-T implantable cardioverter defibrillator (ICD). The recall is issued because there is a potential for premature battery depletion in these devices. The Ilestro 7 DR-T is intended to provide ventricular tachycardia pacing and ventricular defibrillation for the automatic treatment of life-threatening ventricular arrhythmias.
The affected devices are distributed nationwide in the United States and worldwide. The recall includes a specific list of serial numbers associated with the Ilestro 7 DR-T, DF-1, REF383562 model. Patients with these devices should contact their healthcare provider to determine if their specific serial number is affected and to discuss appropriate monitoring or replacement options.
The recalled product
- Product
- BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
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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