BIOTRONIK recalls Ilestro 7 DR-T and DF-4 defibrillators with serial numbers 60744585-60819594. Premature battery depletion may cause device failure. Affected units should be checked for serial numbers listed.
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
BIOTRONIK is recalling certain Ilestro 7 DR-T and DF-4 defibrillators due to a potential risk of premature battery depletion. This could cause the device to stop working properly, which is serious for patients with heart conditions.
The device may run out of battery earlier than expected, causing it to stop working. This could lead to the device failing to treat life-threatening heart rhythm problems, which is dangerous for patients with heart conditions.
Patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) who own the recalled models are affected. Those with the specific serial numbers listed in the recall are most at risk.
Check the serial numbers on your device. The affected models have serial numbers from 60744585 to 60819594 (as listed in the recall). The product is intended for ventricular tachycardia pacing and defibrillation.
Look for the serial number on your device. Affected units have serial numbers between 60744585 and 60819594.
If your device is affected, contact BIOTRONIK directly for further instructions.
The recalled models are BIOTRONIK Ilestro 7 DR-T and DF-4 defibrillators.
Check the serial number on your device. Affected units have serial numbers from 60744585 to 60819594 as listed in the recall.
No, but you should check your serial number. If affected, contact BIOTRONIK for further instructions.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1442-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1442-2021 from BIOTRONIK. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
