Manufacturer
321 recalls in our database name Boston Scientific Corporation as the manufacturing or recalling firm.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Boston Scientific is issuing a software update for multiple pacemaker models to prevent unwanted Safety Mode activation due to high battery impedance in ambulatory settings. The update affects ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2, VISIONIST, and VALITUDE models distributed worldwide.
Boston Scientific is recalling certain ACCOLADE family pacemakers, including ALTRUA 2 models, because a software issue can cause inappropriate Safety Mode activation in ambulatory settings. A software update is available to prevent this malfunction.
Boston Scientific is recalling ACCOLADE and related pacemakers worldwide due to a software issue that may cause unintended Safety Mode activation in ambulatory settings when high battery impedance is detected.
Boston Scientific is recalling pacemakers and cardiac resynchronization therapy devices due to a battery impedance issue that could trigger unwanted Safety Mode in ambulatory settings. A software update is available to prevent this condition.
Boston Scientific is issuing a software update for ESSENTIO and related pacemaker models to prevent inappropriate Safety Mode activation in ambulatory settings when battery impedance is high.
Boston Scientific pacemakers may incorrectly enter safety mode in ambulatory settings when battery impedance is high. A software update is available to fix this issue.
Boston Scientific is recalling ACCOLADE pacemakers due to a software defect that may cause unintended Safety Mode activation when battery impedance is elevated. A software update is available to address this issue.
Boston Scientific is providing a software update to prevent inappropriate Safety Mode activation in PROPONENT and related pacemakers. No illnesses have been reported.
Boston Scientific pacemakers may experience inappropriate Safety Mode activation in ambulatory settings due to high battery impedance. Software to address this issue is available; contact your healthcare provider.
Software recall for Boston Scientific pacemakers and CRT-Ps to prevent Safety Mode from initiating incorrectly due to high battery impedance in ambulatory settings.
Boston Scientific is recalling approximately 41,000 pacemakers and cardiac resynchronization therapy devices due to a software issue affecting Safety Mode in high-battery-impedance conditions. Corrective software is available.
Boston Scientific is recalling certain pacemakers due to potential unintended Safety Mode activation. A software update is available to address the issue in over 34,000 affected devices.
Boston Scientific pacemakers may inappropriately activate Safety Mode in ambulatory settings due to high battery impedance. A software update is available to address this issue.
Boston Scientific pacemakers may incorrectly initiate Safety Mode in ambulatory settings due to a software issue with battery impedance detection. A software update is available to prevent this.
Boston Scientific is recalling specific lot numbers of LGX Preconnect with TENACIO Pump devices due to potential inflation and deflation performance problems that could affect proper operation.
Boston Scientific is recalling certain CX Preconnect pumps due to potential inflation and deflation performance issues that could affect their operation.
Boston Scientific is recalling TENACIO Pump with InhibiZone (UPN 72404429) due to potential inflation and deflation performance issues affecting 59 units distributed in the US and Canada.
Boston Scientific is recalling the TENACIO Pump without InhibiZone (UPN 72404420) due to potential inflation and deflation performance issues. Affected devices were distributed worldwide, including the US and Canada.
Boston Scientific recalls CX Preconnect TENACIO infusion pumps worldwide for potential inflation and deflation performance issues that could affect medication delivery. Approximately 2,288 units were distributed in the US and Canada.
Boston Scientific is recalling LGX Preconnect with TENACIO Pump devices that may experience inflation or deflation performance problems. Approximately 490 units were distributed to the US and Canada.
Boston Scientific is recalling 172 CXR Preconnect with TENACIO pumps due to potential inflation and deflation performance issues. Affected patients should contact their healthcare provider.
Boston Scientific is recalling 156 units of Extractor Pro RX Retrieval Balloon Catheter due to a labeling error that incorrectly describes the skive hole position relative to the balloon.
Boston Scientific is recalling the Preventive Maintenance Kit ICEFX because certain desiccant tube subassemblies have end caps that were not correctly tightened during manufacturing. The affected batch was distributed in Canada, France, Germany, Italy, and the United States.
Boston Scientific is recalling 1,369 UroMax Ultra Kit inflation devices worldwide due to potential migration of foreign material particles into balloon dilation catheters.
Boston Scientific is recalling the NephroMax Kit because foreign material particles could migrate from the inflation device into balloon dilation catheters during use. Worldwide distribution of 458 units.