Medtronic recalls Evera and Visia ICD models with specific serial numbers due to potential shortened replacement time. Affected devices may need replacement to prevent complications.
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
Medtronic is recalling certain implanted cardioverter defibrillators (ICDs) that may have a shortened replacement time. This could lead to device failure if not addressed. Affected models include Evera and Visia families with specific serial numbers.
A small percentage of these devices may experience a shorter-than-expected replacement time, which could lead to device failure if not addressed. This is not a safety hazard in normal use but requires monitoring.
People with implanted cardioverter defibrillators (ICDs) using the Evera or Visia families with specific serial numbers listed in the recall. Most users are at low risk as this is a statistical issue affecting a small percentage of devices.
Check if your device is an Evera or Visia ICD model with the serial numbers listed in the recall. The recall includes specific model names and serial number ranges.
Identify your ICD model (E vera, Visia) and check if it matches the recalled models listed in the recall.
If your device is affected, contact Medtronic directly for further instructions on device replacement.
Medtronic will provide instructions if your device is affected. Replacement may be necessary to prevent complications.
Check your device model and serial number against the list of affected models and serial numbers provided in the recall.
This is a statistical issue affecting a small percentage of devices, not a safety hazard in normal use.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1305-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1305-2021 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.
