41 recalls found for Boston Scientific. Check if any of your products are affected.
Boston Scientific recalled 16,077 ACCOLADE SR SL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent the device from entering Safety Mode in high battery impedance states. Patients must stop using the device immediately and follow manufacturer's instructions.
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.
Boston Scientific recalled 41,009 pacemakers on August 20, 2025, due to a software issue that could trigger Safety Mode. This affects the ACCOLADE family of devices, including the PROPONENT model. Patients should stop using these devices immediately and contact their healthcare provider.
Boston Scientific recalled 32,695 pacemakers on August 20, 2025. The recall affects multiple models due to software that may prevent initiation of Safety Mode. This defect poses a high hazard level to patients who rely on these devices.
Boston Scientific recalled 1,050 cardiac pacemakers on August 20, 2025. The recall affects the VISIONIST and ACCOLADE families of devices due to a software issue. Patients must stop using the devices immediately to prevent potential safety risks.
Boston Scientific recalled 223,163 ESSENTIO DR SL MRI pacemakers on August 20, 2025. The recall addresses a software issue that could prevent the device from functioning properly in certain conditions. Users should stop using the device immediately and follow the manufacturer’s instructions.
Boston Scientific recalled 3,146 units of the L209 PROPONENT DR (VDD) SL Pacemaker on August 20, 2025. The recall addresses a software issue that may cause device malfunction in ambulatory settings. Patients should stop using the device and follow manufacturer instructions immediately.
Boston Scientific recalled 7,488 ACCOLADE DR EL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent the device from entering Safety Mode. Patients should stop using the device immediately and follow recall instructions.
Boston Scientific recalled 1,380 PROPONENT SR SL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent safety mode activation in ambulatory settings. Healthcare providers and patients must stop using the devices immediately.
Boston Scientific recalled 61,700 ESSENTIO SR SL MRI Pacemakers on August 20, 2025, due to a software issue. The software failure can lead to the device entering Safety Mode unexpectedly in high battery impedance situations. Patients must stop using the device immediately and follow recall instructions from their healthcare provider.
Boston Scientific recalled 190,088 ESSENTIO DR EL MRI Pacemakers on August 20, 2025. A software issue may prevent proper device operation in ambulatory settings. Patients must stop using the device immediately and follow recall instructions.
Boston Scientific recalled 4,841 ALTRUA 2 SR SL pacemakers on August 20, 2025. The recall stems from a software issue that may prevent proper device function in patients. Users should stop using the device immediately and follow manufacturer instructions.
Boston Scientific recalled 34,180 ACCOLADE DR EL MRI pacemakers on August 20, 2025. The recall addresses a software issue that may prevent proper function in ambulatory settings. Patients should stop using the devices immediately and contact their healthcare provider.
Boston Scientific recalled 3,592 units of the Model L221 PROPONENT DR EL Pacemaker on August 20, 2025. The recall addresses a software issue that may prevent proper device functioning due to high battery impedance. Patients and healthcare providers must stop using the device immediately and follow the recall instructions.
Boston Scientific recalled 4,055 ALTRUA 2 DR SL Pacemakers on August 20, 2025, due to a software issue. This software can prevent the device from initiating Safety Mode in certain conditions. Patients should stop using the device immediately and follow recall instructions.
Boston Scientific recalled 41,191 pacemakers on August 20, 2025, due to a software issue that may prevent proper safety functions. The recall affects several models in the ACCOLADE and VISIONIST families of devices. Patients should stop using the devices immediately and follow manufacturer instructions.
Boston Scientific recalled one unit of the Preventive Maintenance Kit ICEFX on August 18, 2025. Certain desiccant tube subassemblies had improperly tightened end caps. This recall affects distribution in the US, Canada, France, Germany, and Italy.
Boston Scientific recalled 19 units of the ICEfx Cryoablation System on August 18, 2025. The recall stems from improperly tightened end caps on certain desiccant tube subassemblies. Patients and healthcare providers should stop using the device immediately.
Boston Scientific recalled 1,369 UroMax Ultra Kits on August 5, 2025. Foreign particles may migrate from the Encore 26 Inflation Device into balloon dilation catheters. Patients and healthcare providers must stop using the device immediately.
Boston Scientific recalled 458 NephroMax Kits on August 5, 2025, due to contamination risk. The Encore 26 Inflation Device may allow foreign particles to enter balloon dilatation catheters. Patients must stop using the device immediately and follow recall instructions.