BIOTRONIK Iforia 7 Defibrillators Recalled for Premature Battery Depletion
BIOTRONIK is recalling 490 Iforia 7 implantable defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the failure of a life-sustaining medical device (premature battery depletion in a defibrillator), which poses a significant risk of serious injury or death if the device fails to treat a life-threatening arrhythmia.
Plain-English summary
BIOTRONIK Inc is recalling 490 units of the Iforia 7,DR-T, 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 these devices. The affected units are identified by specific serial numbers and the UDI 04035479126926.
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.
Patients with these devices should contact their healthcare provider or BIOTRONIK Inc to determine if their specific device is affected and to discuss appropriate monitoring or replacement options.
The recalled product
- Product
- BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 490
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.
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