FDA recall notice

Percutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid…

FDA Recall Confirmed · Percutaneous Catheter · posted Aug 26, 2026

Key facts

Notice Percutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid Neuroprotection System
Device type Percutaneous Catheter
Status Recall Confirmed
Posted Aug 26, 2026
Notice on fda.gov fda.gov

At a glance

  • Confirmed Recall confirmed
  • Yes Currently listed by the FDA
  • 1–9 Recall events referenced
  • None UDI device identifiers named

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recall notices and early alerts

The FDA's Medical Device Recalls and Early Alerts list covers the most serious device recalls, plus early alerts about potentially high-risk device issues while the FDA is still collecting information. A notice is updated as the recall is confirmed or changes.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls and Early Alerts · Source date:

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