Boston Scientific recalls ALTRUA 2 DR Pacemaker models S702 and S722 built before September 2018 due to potential safety mode activation during normal use. Affected units have specific serial numbers and UDI-DI codes.
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Boston Scientific is recalling certain ALTRUA 2 DR Pacemaker models (S702 and S722) made before September 2018 because they have a higher risk of entering safety mode during normal operations. This could cause the device to stop working properly without warning.
These pacemakers can enter safety mode during normal operations like telemetry checks or higher-power functions due to latent high battery impedance. This may cause the device to stop working unexpectedly without warning.
People with these specific pacemaker models who were implanted before September 2018 are most at risk. The recall affects a limited number of units with unique serial numbers and UDI-DI codes.
Check if your pacemaker has model numbers S702 or S722 and was manufactured before September 2018. Affected units have specific serial numbers listed in the recall notice or UDI-DI codes starting with 00802526559358.
Identify if your pacemaker is model S702 or S722 with serial numbers listed in the recall notice.
Reach out to Boston Scientific directly for verification and instructions on next steps.
The recall does not require replacement; Boston Scientific will provide guidance on next steps based on your device.
Check your device's model number and serial number against the list of affected units provided in the recall notice.
Yes, the device may enter safety mode during normal operations, which could cause unexpected malfunction.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0825-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0825-2025 from Boston Scientific. 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.
