Boston Scientific recalled 28,911 VALITUDE CRT-P EL MRI pacemakers on August 20, 2025, due to a software issue that may prevent proper device function. The recall affects specific models from the ACCOLADE family of devices. Patients and healthcare providers should stop using these devices immediately.
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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The recalled product is the VALITUDE CRT-P EL MRI with model number U128. It was distributed worldwide and includes multiple serial numbers. Specific serial numbers affected include 100187, 100217, and others.
The recall stems from a software issue designed to enhance safety architecture. This issue may lead to the initiation of Safety Mode in ambulatory settings due to high battery impedance.
No specific incidents or injuries have been reported related to this recall. However, the potential hazard poses a high risk to patient safety.
Patients must stop using the device immediately. Contact Boston Scientific or a healthcare provider for further instructions and follow the recall process.
For assistance, call Boston Scientific Corporation or visit their website for details. Notification will be sent via letter.
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