BIOTRONIK Ilestro 7 VR-T DX Defibrillators Recalled for Battery Depletion
BIOTRONIK Inc is recalling 3,664 Ilestro 7 VR-T DX implantable defibrillators 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, and the hazard involves a life-sustaining medical device (ICD/CRT-D) with a risk of premature battery depletion, which aligns with the rubric for significant injury risk or high-severity device defects.
Plain-English summary
BIOTRONIK Inc is recalling 3,664 units of the Ilestro 7 VR-T DX, DF-1 implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D). 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 Inc for further instructions regarding the recall and potential replacement or monitoring.
The recalled product
- Product
- BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 3,664
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
- 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
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- HighBiotronik ILIVIA 7 ICD Recall for Premature Battery Depletion
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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
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- 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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