Biotronik Ilestro 7 VR-T Defibrillators Recalled for Battery Depletion Risk
Biotronik is recalling 323 Ilestro 7 VR-T defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.
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 involves a life-sustaining medical device (ICD/CRT-D) where premature battery depletion could result in significant injury or death if the device fails to treat life-threatening arrhythmias.
Plain-English summary
Biotronik Inc is recalling 323 units of the Ilestro 7 VR-T, DF-4 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 units are identified by specific serial numbers listed in the recall notice and have a UDI of 04035479125363.
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. The agency has classified this recall as Class II.
Patients with these implanted 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 recall number is Z-1444-2021.
The recalled product
- Product
- BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 323
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
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