Boston Scientific recalled 22,714 ESSENTIO DR SL pacemakers on August 20, 2025. Software updates are necessary to prevent initiation of Safety Mode due to high battery impedance. The recall affects multiple models including the ACCOLADE and VISIONIST series.
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 includes model number L101 of the ESSENTIO DR SL pacemaker. The affected units have been distributed worldwide.
The software issue may cause the pacemaker to enter Safety Mode unexpectedly in ambulatory settings. This poses a high hazard level to patients who rely on consistent cardiac support.
No specific incidents or injuries have been reported as a result of this software issue. The recall is classified as Class I due to the potential for serious consequences.
Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by Boston Scientific, and contact your healthcare provider for further guidance.
For more information, patients can contact Boston Scientific Corporation directly or visit their website for recall instructions.
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