Medtronic's ICD-VR DVFB1D1 VISIA AF MRI US DF1 devices have a rare risk of reduced or no energy output during high voltage therapy. Affected units include specific lot numbers listed in the recall. Contact Medtronic for details.
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Medtronic's ICD-VR DVFB1D1 VISIA AF MRI US DF1 implantable cardioverter defibrillators have a rare risk of reduced or no energy output during high voltage therapy. This could potentially lead to treatment failure if the device doesn't deliver the required energy. The recall includes specific lot numbers that users should check against.
The device uses a glassed feedthrough that can sometimes cause reduced or no energy output during high voltage therapy (typically 0-12J). This means the device might not deliver the necessary electrical energy to treat heart arrhythmias, potentially leading to treatment failure.
People with Medtronic ICD-VR DVFB1D1 VISIA AF MRI US DF1 implantable cardioverter defibrillators. The risk is rare and only affects specific units with a glassed feedthrough.
Check if your device has the model number DVFB1D1 and lot numbers listed in the recall (e.g., CWG208686H, CWG211264H). The device is an implantable cardioverter defibrillator (ICD) used for heart rhythm management.
Verify your device's model number is DVFB1D1 and lot number matches the list provided in the recall.
Reach out to Medtronic for specific guidance on whether your device is affected and what actions to take.
The risk is rare and only affects specific units with a glassed feedthrough. It could lead to reduced or no energy output during high voltage therapy, but serious injury is not typical.
Check if your device has the model number DVFB1D1 and a lot number from the list provided in the recall (e.g., CWG208686H, CWG211264H).
The recall does not specify a replacement requirement. Contact Medtronic for details on whether your device needs repair or replacement.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1803-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1803-2023 from Medtronic. 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.
