BIOTRONIK recalls Iforia 7, vr-T, DX, DF-1 devices with serial numbers starting 60724952 through 60821620 for potential premature battery depletion in implantable cardiac devices.
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
BIOTRONIK is recalling certain Iforia 7, vr-T, DX, and DF-1 implantable cardiac defibrillators due to a potential risk of premature battery depletion. This could lead to device failure and require replacement.
The devices may experience premature battery depletion, which could cause the device to stop functioning properly. This might require replacement but does not pose an immediate risk of injury.
Patients with these specific implantable cardiac defibrillators are affected. The risk is low as the hazard involves battery depletion rather than immediate injury.
Check if your device has a serial number listed in the range 60724952 to 60821620. These are specific models of implantable cardiac defibrillators.
Look for the serial number on your device, which should be between 60724952 and 60821620.
No action is needed if your device's serial number is not in the list provided.
The device may need to be replaced by a healthcare provider to prevent failure.
The hazard is low risk as it involves potential battery depletion rather than immediate injury.
We’ve drafted a message you can send BIOTRONIK to request your refund or repair — edit it as you like.
Subject: Recall Z-1447-2021 — BIOTRONIK BIOTRONIK Hello, I own a BIOTRONIK that is covered by recall Z-1447-2021 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.
