Medtronic recalls certain CRT-P pacemakers that may have a longevity estimation error in early device life, potentially affecting device lifespan. Owners should contact Medtronic for guidance.
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
Medtronic is recalling some cardiac pacemakers that could have an error in estimating how long the device will last. This error might cause the device to fail earlier than expected, which could lead to health risks for users.
The pacemaker may incorrectly estimate the device's remaining lifespan during early use. This could lead to the device failing before it should, potentially causing health issues for the user.
People with Medtronic CRT-P pacemakers that were implanted with a unipolar pacing vector in the right atrial or right ventricular lead. Those who have the specific Percepta, Serena, or Solara families of devices with MRI SureScan are most at risk.
Check if your pacemaker is a Percepta, Serena, or Solara family model with MRI SureScan. These devices were sold with specific codes that include the names of the families.
Reach out to Medtronic directly for guidance on whether your device is affected and what steps to take next.
The recall does not specify an immediate stop-use requirement. Contact Medtronic for guidance.
Percepta, Serena, and Solara families with MRI SureScan models.
Check if your device is a Percepta, Serena, or Solara family model with MRI SureScan. These devices were sold with specific codes that include the names of the families.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1526-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1526-2021 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.
