Medtronic recalls ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL implantable defibrillators with specific glassed feedthroughs that may cause reduced or no energy output during high-voltage therapy. Affected units have GTIN 00643169218017 or 00643169969582 with listed serial numbers.
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 is recalling certain ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL implantable defibrillators due to a rare risk of reduced or no energy output during high-voltage therapy. This could potentially affect the device's ability to treat heart conditions if the patient requires a shock.
The device uses a specific type of glassed feedthrough that can occasionally fail to deliver sufficient energy during high-voltage therapy (typically 0-12 joules). This may cause the device to not properly treat heart arrhythmias in rare cases, but the risk is very low and only happens under specific therapy conditions.
People with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) using the recalled model. Most users are likely safe as the risk is rare and only occurs under specific high-voltage therapy conditions.
Check if your device has the model number DVBB2D1 and GTIN 00643169218017 or 00643169969582. Serial numbers listed in the recall include many 'BWK' prefixes followed by numbers and 'S' (e.g., BWK607537S).
Verify your device model is DVBB2D1 and has the GTIN 00643169218017 or 00643169969582.
If your device is affected, contact Medtronic directly for further instructions.
The recall describes a rare potential for reduced or no energy output during high-voltage therapy, but the risk is very low and only occurs under specific conditions. Most users are safe.
Check if your device has the model number DVBB2D1 and GTIN 00643169218017 or 00643169969582 with serial numbers listed in the recall.
If your device is affected, contact Medtronic directly for further instructions. There is no immediate action required for unaffected devices.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1797-2023 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1797-2023 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.
