Boston Scientific recalls 223,163 pacemakers worldwide due to software issues affecting Safety Architecture. The recall covers ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 DR devices and VISIONIST and VALITUDE CRT-Ps. The defect prevents initiation of Safety Mode when battery impedance is high. Patients should stop using the device 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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Pacemakers provide heart rhythm management for patients with bradycardia or heart block. MRI compatibility improves imaging but requires safe architecture. This recall concerns high impedance battery states affecting Safety Mode.
Software intended to enhance Safety Architecture may fail to initiate Safety Mode during high impedance battery conditions, potentially compromising patient safety during ambulatory use.
This recall is not indicated as part of a broader industry pattern in the provided data.
Significant risk to patients who rely on pacemakers; immediate action required; potential device reprogramming or replacement depending on clinical guidance.
Official recall notices on FDA site and Boston Scientific notifications; serial numbers and GTINs listed in vendor communications
Recall remedies may involve device replacement or software patch; timelines vary by patient and clinical setting
Keep copies of all recall notices, physician correspondence, and replacement/refund confirmations
Model Number L111, ESSENTIO DR SL MRI Pacemaker. Devices include ACCOLADE family models and VISIONIST VALITUDE CRT-Ps. Distribution worldwide. Quantity: 223,163 units. Serial numbers and GTINs listed in records.
No specific injuries or incidents are provided in the data. The status is ACTIVE with a HIGH hazard level.
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