Biotronik Iperia 7 Defibrillators Recalled for Premature Battery Depletion
Biotronik is recalling 1,652 Iperia 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 with a potential for failure (premature battery depletion), which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biotronik Inc is recalling 1,652 units of the Iperia 7, DR-T, DF-1, ProMRI Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). The recall is issued 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.
Patients with these specific devices should contact their healthcare provider or Biotronik for instructions on monitoring the device battery status and potential replacement.
The recalled product
- Product
- BIOTRONIK Iperia 7, DR-T, DF-1, ProMRI REF 392409, UDI: 04035479128777 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 1,652
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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