FDA Classifies Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall as Class I
FDA has classified the recall of Boston Scientific ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus as Class I due to reports of arterial sheath tip separation during clinical use.
Decision support
Decision summary
Official recall information is separated from MedTech Current editorial analysis.
Official recall information
What happened
Boston Scientific initiated a voluntary removal for specified lots after reports of arterial sheath tip separation or partial tip separation during clinical use. A detached tip may remain in the patient's vasculature and require endovascular or open surgical retrieval. FDA identifies potential complications including vascular embolism, stroke, transient ischemic attack, restenosis, and thrombosis; one serious injury and no deaths had been reported as of July 9, 2026.
MedTech Current analysis
Why it matters
The failure mode can leave a component in a patient's vasculature during a neurovascular procedure, creating a severe patient-safety risk and a time-critical retrieval decision. Facilities need lot-level traceability and inventory controls because only specified lots are affected, while manufacturers should review bond-integrity and complaint-escalation controls for comparable transcarotid access systems.
Official recall information
Official actions
According to the FDA communication and Boston Scientific's removal notice:
- Immediately discontinue clinical use of affected products and quarantine remaining inventory.
- Complete and return the Reply Verification Tracking Form to the Boston Scientific Field Action Center, including when no affected units remain in inventory.
- Obtain a Return Goods Authorization number, label packages with the assigned number, and return segregated units using the instructed shipping process.
- Notify relevant clinical, supply-chain, and downstream recipient teams that may hold transferred product.
Detailed recall information
Detailed sourced information from the published Recall Brief follows.
What changed
Boston Scientific Corporation initiated a voluntary medical-device removal for specific lots of the ENROUTE Transcarotid Neuroprotection System (NPS) and ENROUTE Transcarotid Neuroprotection System Plus (NPS Plus). On August 26, 2026, the U.S. Food and Drug Administration updated its communication to classify this removal as a Class I recall, following an initial Early Alert posted on July 24, 2026.
The action was initiated due to reports of arterial sheath tip separation or partial tip separation during clinical use. The ENROUTE Transcarotid System is intended to capture and transport emboli away from carotid artery circulation by establishing temporary blood-flow reversal at the treatment site before and during carotid artery lesion manipulation. When arterial sheath tip separation occurs, the detached component may remain within the patient’s vasculature, potentially requiring endovascular or open surgical retrieval. According to the FDA communication, complications associated with a retained tip include vascular embolism, stroke, transient ischemic attack (TIA), restenosis, or thrombosis. As of July 9, 2026, Boston Scientific reported one serious injury and zero deaths associated with the failure mode.
Who and what are affected
The removal affects 164,687 total units distributed worldwide across the United States, Australia, Canada, China, and Jamaica. The affected devices were manufactured by Boston Scientific Corporation and may be cataloged under Silk Road Medical within hospital inventory systems.
| Product Name | Material Number | GTIN | Recall Number | Quantity Affected |
|---|---|---|---|---|
| ENROUTE Transcarotid Neuroprotection System | SR-200-NPS | 00811311020829 | Z-2977-2026 | 115,458 units |
| ENROUTE Transcarotid Neuroprotection System Plus | SR-250-NPS | 00811311021062 | Z-2978-2026 | 49,229 units |
The removal applies exclusively to specified lots. Consignees should refer to the primary FDA notice and Boston Scientific’s removal letter for the complete list of affected lot numbers.
What affected organizations should do
Affected healthcare facilities
According to the FDA communication and Boston Scientific’s Urgent Medical Device Removal notice:
- Immediately discontinue the clinical use of affected products and quarantine remaining inventory.
- Complete and return the Reply Verification Tracking Form to the Boston Scientific Field Action Center via email (
BSCFieldActionCenter@bsci.com) or fax (1-763-415-7708) to receive a Return Goods Authorization (RGA) number. - Submit the RVTF acknowledgment even if your facility has zero affected units in current inventory.
- Label packages with the assigned RGA number and return all segregated units to Boston Scientific’s Quincy, Massachusetts distribution center using the prepaid FedEx account (
9205-2515-6). - Notify relevant surgical, neurointerventional, and supply-chain personnel within your institution who use or manage these devices.
- Forward the removal notice immediately to any external facility or department to which affected devices may have been transferred.