Medtronic recalls Azure S DR MRI SureScan devices with specific serial numbers due to potential battery failure that could lead to cardiac arrest or hospitalization. Affected units must be checked for serial numbers RNJ108800G to RNJ108820G.
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
Medtronic is recalling certain Azure S DR MRI SureScan devices because they may suddenly lose power without warning, which could cause heart problems or require surgery. This is serious and affects people with implanted devices.
The devices may suddenly lose power without warning, causing the device to stop working. This can lead to insufficient heart support, resulting in cardiac arrest, fainting, or hospitalization. In some cases, the device may need to be replaced surgically, increasing the risk of infection or bleeding.
People with implanted Medtronic Azure S DR MRI SureScan devices, especially those with specific serial numbers RNJ108800G to RNJ108820G, are at risk. The hazard is most severe for individuals who rely on the device for cardiac therapy.
Check the serial number on your device, which is listed as RNJ108800G to RNJ108820G. The product was sold with specific serial numbers and UDI-DI codes starting with 00763000956004.
Immediately stop using the device if you have the affected serial numbers listed.
Serial numbers RNJ108800G, RNJ108808G, RNJ108810G, RNJ108803G, RNJ108804G, and RNJ108820G.
The device may suddenly lose power without warning, which can cause heart problems or require surgery, leading to risks like cardiac arrest, fainting, or infection.
The recall includes a potential need for surgical revision (explant/replacement) to fix the issue, which carries risks of infection or bleeding.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1924-2025 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1924-2025 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.
