BIOTRONIK IPERIA 7 ICDs Recalled for Premature Battery Depletion
BIOTRONIK Inc is recalling 2,881 IPERIA 7 ICDs and CRT-Ds due to a potential for premature battery depletion.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 Class II medical device with a potential for premature battery depletion, which poses a risk of harm if the device fails to treat life-threatening arrhythmias, but no injuries or illnesses have been reported.
Plain-English summary
BIOTRONIK Inc is recalling 2,881 units of the BIOTRONIK IPERIA 7, DR-T DF4 ProMRI (REF 392423) medical devices. These devices are intended to provide ventricular tachycardia pacing and ventricular defibrillation for the automatic treatment of life-threatening ventricular arrhythmias.
The recall is issued because there is a potential for premature battery depletion in these Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). The affected devices were distributed nationwide in the United States and worldwide.
Patients with these specific devices should contact their healthcare provider or BIOTRONIK Inc for further instructions regarding the recall and necessary follow-up care.
The recalled product
- Product
- BIOTRONIK IPERIA 7, DR-T DF4 ProMRI, REF 392423, UDI: 04035479128913 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 2,881
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
Same manufacturer · BIOTRONIK Inc
See all →- HighBiotronik Inventa 7 ICDs Recalled for Premature Battery Depletion
FDA (Devices) · 2021-04-28
- SevereBIOTRONIK Ilestro 7 VR-T DX Defibrillators Recalled for Battery Depletion
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- HighBiotronik ILIVIA Neo 7 VR-T DF-1 ProMRI Recall for Battery Depletion
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- HighBiotronik Intica Neo 7 VR-T DX DF-1 ProMRI Recall for Battery Depletion
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- SevereBiotronik Inventa 7 Defibrillators Recalled for Premature Battery Depletion
FDA (Devices) · 2021-04-28
Same hazard · battery depletion
See all →- ModerateAllura Xper FD20 OR Table systems recalled over BIOS battery depletion
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- ModerateAllura Xper FD10/10 X-ray systems recalled for BIOS battery startup failure
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- ModerateAllura Xper FD20/20 X-ray systems recalled for BIOS battery startup failure
FDA (Devices) · 2025-10-08
- ModerateAllura Xper CV20 X-ray systems recalled after BIOS battery halts startup
FDA (Devices) · 2025-10-08
- ModerateAllura Xper FD20/15 OR Table systems recalled over BIOS battery depletion
FDA (Devices) · 2025-10-08
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