Boston Scientific recalled 1,380 pacemakers worldwide on August 20, 2025, due to software intended to enhance Safety Architecture. The devices include ACCOLADE family models and VISIONIST and VALITUDE CRT-Ps. The defect could prevent initiation of Safety Mode in ambulatory settings. Patients should stop using the devices and follow manufacturer instructions.
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).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
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These pacemakers provide cardiac rhythm management for patients with arrhythmias. They are implanted devices that regulate heartbeats through electrical impulses.
A software improvement intended to bolster Safety Architecture may inadvertently prevent Safety Mode activation when a high battery impedance state occurs, potentially compromising device safety.
This recall is not described as part of a broader pattern in the provided data.
The recall affects a small population of device patients worldwide. The immediate safety action is to stop using the product per manufacturer guidance, with a focus on medical supervision.
Review device label and patient documentation supplied with the implant; check FDA recall page linked to enforcement report Z-0085-2026
Remedial actions and replacements will be communicated by the manufacturer; timelines vary by device and clinical needs
Keep the recall letter, device serials, GTINs, and all correspondence with Boston Scientific and healthcare providers
Model: PROPONENT SR SL (Model L200). Classification: Class I recall. Quantity: 1,380 units. Distribution: Worldwide. Brands involved: Boston Scientific. Devices involved in ACCOLADE family including ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL and EL, and VISIONIST and VALITUDE CRT-Ps. GTINs and serial numbers listed include GTIN 00802526559020 with serials 722605, 722614, 722634, 722647; GTIN 00802526576362 with serials 464359, 464382, 464387, 464444, 464447, 464457, 464462, 464471, 464505, 464511, 464514, 464517, 464521, 464525, 464527.
No incidents or injuries are documented in the provided data.
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