Biotronik Ilestro 7 VR-T Defibrillators Recalled for Premature Battery Depletion
Biotronik Inc is recalling 1,000 Ilestro 7 VR-T implantable 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 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 is classified as FDA Class II, and the hazard involves a life-sustaining medical device (defibrillator) with a potential for failure (premature battery depletion). No injuries or deaths are reported, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biotronik Inc is recalling 1,000 units of the Ilestro 7 VR-T, DF-1 (REF 383578) implantable cardioverter defibrillators. The recall is due to a potential for premature battery depletion in these devices, which are intended to provide ventricular tachycardia pacing and ventricular defibrillation for the automatic treatment of life-threatening ventricular arrhythmias.
The affected devices were distributed nationwide in the United States and worldwide. The recall notice lists specific serial numbers for the affected units. No illnesses, injuries, or deaths have been reported in the source text.
Consumers and healthcare providers should check the serial numbers of their devices against the list provided in the official recall notice. If a device is affected, they should contact Biotronik Inc or their healthcare provider for instructions on replacement or repair.
The recalled product
- Product
- BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
- Manufacturer
- BIOTRONIK Inc
- Affected units
- 1,000
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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