Boston Scientific Recalls ENROUTE Transcarotid System
The device maker pulled the ENROUTE Transcarotid Neuroprotection System Plus after the FDA classified a Class I recall over potential arterial sheath tip separation.
Boston Scientific (BSX) recalled the ENROUTE Transcarotid Neuroprotection System Plus, material number SR-250-NPS, a percutaneous catheter, in a Class I action reported Aug. 26, 2026.
The FDA said the recall was for potential arterial sheath tip separation or partial tip separation during use. The agency listed the status as ongoing and the basis as voluntary, firm-initiated. Distribution was worldwide, including nationwide U.S. sales and foreign shipments to Australia, Canada, China, and Jamaica.
The company identified a cybersecurity incident on Aug. 25, 2026, affecting certain information technology systems and causing a global disruption to operations. Boston Scientific said it activated incident-response protocols and began an investigation with third-party cybersecurity experts to assess and contain the threat. The incident has caused, and is expected to continue to cause, disruptions and limitations of access to systems that support aspects of operations, including the ability to process and ship customer orders. The company said the timeline for a full restoration is not yet known and that the full scope, nature, and impacts, including operational and financial impacts, are not yet known. It has not yet determined whether the incident is reasonably likely to have a material impact.
The same day, Boston Scientific listed cybersecurity-related items among factors that may cause results to differ, including disruptions caused by cybersecurity events, the results of the investigation, any impairment to systems or data, delays in restoring systems, the adequacy of processes during disruption, potential litigation related to the incident, and reputational risk or regulatory scrutiny.
The voluntary, firm-initiated Class I recall of the ENROUTE system remains ongoing as of the FDA record, with the stated reason limited to the potential for arterial sheath tip separation or partial tip separation during use.