The Recall Desk
HighFDA (Devices)·Z-1442-2021·Announced 2021-04-28

Biotronik Ilestro 7 DR-T Recall for Premature Battery Depletion

Biotronik is recalling Ilestro 7 DR-T implantable defibrillators due to a potential for premature battery depletion. Affected 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 is classified as FDA Class II and involves a life-sustaining medical device (ICD) with a risk of failure (premature battery depletion), but the source text does not report any specific injuries or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biotronik Inc is recalling specific units of the Ilestro 7 DR-T 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 product is intended to provide ventricular tachycardia pacing and ventricular defibrillation for the automatic treatment of life-threatening ventricular arrhythmias.

The recall affects specific serial numbers of the Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202. The distribution pattern for these devices is nationwide in the United States and worldwide. The source text does not specify the total number of affected units or report any specific illnesses or injuries.

Patients with these specific serial numbers should contact their healthcare provider or Biotronik Inc to determine if their device is affected and to discuss appropriate medical management. The recall is classified as Class II by the FDA.

The recalled product

Product
BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
Manufacturer
BIOTRONIK Inc
Category
Medical Device — Implantable Cardioverter Defibrillator
Hazard

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 →

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