Boston Scientific recalled 12,326 pacemakers on August 20, 2025 due to a software issue. The defect can prevent the device from entering Safety Mode, posing a high risk of malfunction. Patients should stop using the devices and follow recall procedures 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 involves the U225 VISIONIST CRT-P EL pacemaker and other models in the ACCOLADE family. Devices were distributed worldwide. The affected models include serial numbers ranging from 709683 to 709912.
The software flaw can prevent the device from entering Safety Mode due to a high battery impedance state. This malfunction increases the risk of device failure in an ambulatory setting.
No specific incidents or injuries have been reported due to this software issue. The recall was initiated as a precaution to prevent potential risks.
Patients and healthcare providers should stop using the recalled devices immediately. Contact Boston Scientific Corporation or healthcare providers for further instructions.
For more details, call Boston Scientific at 1-800-XXX-XXXX or visit their website at www.bostonscientific.com.
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