Boston Scientific Recalls ENROUTE Transcarotid System
Boston Scientific (BSX) issued a Class I recall of the ENROUTE Transcarotid Neuroprotection System after the FDA cited potential arterial sheath tip separation during use.
Boston Scientific (BSX) recalled the ENROUTE Transcarotid Neuroprotection System, a percutaneous catheter identified by material number SR-200-NPS, in a Class I action the company initiated voluntarily.
The FDA stated the reason as a potential for arterial sheath tip separation or partial tip separation during use. The recall, numbered Z-2977-2026, was reported on Aug. 26, 2026, and remained ongoing.
Distribution was worldwide, covering the United States nationwide and foreign markets including Australia, Canada, China, and Jamaica.
The same week, Boston Scientific disclosed a cybersecurity incident that disrupted operations and limited access to systems supporting the processing and shipping of customer orders. The timeline for full restoration was not yet known, and the company had not determined whether the incident was reasonably likely to have a material impact.
The company listed cybersecurity-related disruptions among factors that could cause results to differ from expectations, including delays in restoring systems and the adequacy of processes during the disruption.