Boston Scientific recalled 3,620 VALITUDE CRT-P pacemakers on August 20, 2025, due to a software flaw. The issue may prevent the device from operating correctly in ambulatory settings. Patients and healthcare providers must stop using the device 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 recall affects model number U125, VALITUDE CRT-P pacemakers. They were distributed worldwide and sold as part of the ACCOLADE family of devices.
A software issue may lead to the initiation of Safety Mode due to high battery impedance. This malfunction could impact the device's performance, posing a serious risk to patients.
No specific incidents of injury or death related to this recall have been reported. However, the potential risks associated with device malfunction are significant.
Patients should stop using the device immediately. Contact Boston Scientific or your healthcare provider for further instructions and to follow the recall process.
For more details, contact Boston Scientific Corporation at 1-800-123-4567 or visit their website at www.bostonscientific.com.
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