FDA-Device2026-08-26Class IPROCESSING DEFECT
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus recalled for arterial sheath tip separation risk
What this means
Boston Scientific's ENROUTE Transcarotid Neuroprotection System Plus (a catheter used in certain vascular procedures) may experience separation or partial separation of the arterial sheath tip during use. The FDA has classified this as a Class I recall, the most serious type. Approximately 49,229 units with specific lot numbers are affected and were distributed worldwide.
- If you are a healthcare facility or physician, check your inventory for the affected lot numbers listed in the recall notice.
- Do not use affected units. Contact Boston Scientific for instructions on device return or replacement.
- Consult the FDA's full recall notice for the complete list of affected lot numbers and further guidance.
The agency's original wording
Hazard
Potential for arterial sheath tip separation or partial tip separation during use.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica
Affected count
49,229 units
Manufactured in
1 Scimed Pl, Maple Grove, MN, United States
Products
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2978-2026More Boston Scientific recalls
- FDA-Device2026-09-30Boston Scientific Imager II Angiographic Catheters recalled for catheter tip fracture risk
- FDA-Device2026-09-23Boston Scientific StoneSmart Connect Console power adapters recalled for electrical grounding failure risk
- FDA-Device2026-09-09Boston Scientific LUX-Dx insertable cardiac monitor server software recalled for delayed AF alert notification
- FDA-Device2026-09-09Boston Scientific LUX-Dx cardiac monitor system recalled for delayed alert notifications
- FDA-Device2026-09-09Boston Scientific LUX-Dx cardiac monitor server software recalled for delayed alert notifications
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