Medtronic recalls certain implantable pulse generators for potential longevity estimation error in early device life. This could affect devices used for arrhythmia treatment or heart failure therapy.
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 certain implantable pulse generators that may have a longevity estimation error in early device life. This could lead to incorrect device lifespan predictions, potentially affecting patients receiving treatment for arrhythmias or heart failure.
The device may show an incorrect lifespan estimate when a unipolar pacing vector is programmed in the right atrial or right ventricular leads during early device life. This could lead to premature device replacement or unnecessary replacement.
Patients with Medtronic implantable pulse generators for arrhythmia treatment or heart failure therapy are likely affected. Those with devices from the Azure or Astra families are most at risk.
Check if your device is from the Azure XT DR MRI SureScan, Azure S DR MRI SureScan, Azure XT SR MRI SureScan, Azure S SR MRI SureScan, or Astra XT DR MRI SureScan, Astra XT SR MRI SureScan families. These devices were sold for treating arrhythmias or heart failure.
Reach out to Medtronic directly to confirm if your device is affected and get guidance on next steps.
The recall does not require immediate discontinuation of use. Patients should contact Medtronic for specific guidance.
The error may cause incorrect lifespan estimates in early device life, potentially leading to premature or unnecessary device replacement.
Azure XT DR MRI SureScan, Azure S DR MRI SureScan, Azure XT SR MRI SureScan, Azure S SR MRI SureScan, and Astra XT DR MRI SureScan, Astra XT SR MRI SureScan devices.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1525-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1525-2021 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.
