Boston Scientific recalls PROPONENT SR SL (Model L200) pacemakers with specific serial numbers and GTINs for a potential software safety issue that could lead to device malfunction.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Boston Scientific is recalling specific models of PROPONENT SR SL pacemakers (Model L200) due to a software issue that could cause the device to enter a safety mode. This recall affects patients using these devices and requires them to contact the manufacturer for a software update.
The software update is designed to prevent the device from entering a safety mode when a high battery impedance state occurs. This could lead to the device malfunctioning, but the recall indicates that the software update is available to address this issue.
Patients with PROPONENT SR SL (Model L200) pacemakers who have the specific serial numbers or GTINs listed in the recall are affected. Those with these devices are at risk of potential device malfunction due to the software issue.
Check if your pacemaker has the PROPONENT SR SL (Model L200) with the specific serial numbers or GTINs listed in the recall. The recall includes detailed serial numbers and GTINs for identification.
Reach out to Boston Scientific to confirm your device model and serial number to determine if it's affected by this recall.
Check if your pacemaker has the PROPONENT SR SL (Model L200) with the specific serial numbers or GTINs listed in the recall.
Contact Boston Scientific to confirm your device model and serial number and follow their instructions for the software update.
The recall states that the software update is designed to prevent device malfunction, but the specific risk level is not detailed in the official notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0085-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0085-2026 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.
