Boston Scientific recalled 16,077 ACCOLADE family pacemakers distributed worldwide. The devices include ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 DR SL and EL pacemakers, plus VISIONIST and VALITUDE CRT-Ps. Patients and healthcare providers should stop using the devices immediately and follow the recall 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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ACCOLADE pacemakers are cardiac rhythm management devices used to regulate heart rhythm. The ACCOLADE family includes multiple models and CRT-P devices such as Visionist and Valitude.
A software enhancement intended to strengthen Safety Architecture could prevent Safety Mode activation when battery impedance is high. This creates a risk to patient safety in ambulatory settings.
This recall is not part of a broader industry pattern.
The recall poses a high safety risk to patients relying on these devices. Urgent action is required to stop use and contact clinicians.
Serial numbers are on device labeling and accompanying paperwork. GTIN is on packaging. Manufacturer recall notices provide full lists.
Not specified in the recall notice. Processing for replacements or actions will be provided by the manufacturer.
Keep the recall letter, device identification, serial numbers, and all communications.
Brand: Boston Scientific Device family: ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR SL/EL pacemakers; Visionist CRT-P; Valitude CRT-P Model numbers: ACCOLADE SR SL (Model L300); GTIN 00802526558900 Serial numbers: 464190, 464192, 464197, 464228, 464229, 464230, 464238, 464258, 464279, 464295, 464296, 464316, 464321, 464358, 464360, 464361, 464362, 464363, 464369 Distribution: Worldwide Sold since: Unknown Price: Unknown Quantity recalled: 16,077 Country of origin: Unknown
No injuries or incidents have been reported.
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