Practical implication
Facilities using these devices must immediately cease their use, segregate them from other stock, and return them to Boston Scientific. Relevant personnel must be notified of this recall.
Boston Scientific is recalling specific lots of the ENROUTE Transcarotid Neuroprotection System because of risks associated with arterial sheath tip separation during use. The FDA categorizes this recall as Class I, indicating it poses a significant risk of serious injury or death. Affected users are instructed to stop use, segregate, and return the products to Boston Scientific immediately.
What changed: The FDA classified the recall of the ENROUTE Transcarotid Neuroprotection System as a Class I Recall, requiring all affected products to be removed from circulation.
Why it matters: The device poses significant risks including serious injury or death due to potential complications like embolism and stroke. Immediate action is necessary to ensure patient safety.
Practical implication: Facilities using these devices must immediately cease their use, segregate them from other stock, and return them to Boston Scientific. Relevant personnel must be notified of this recall.
View original source
- Source: FDA - MedWatch Safety Alerts RSS
- Published at source: 2026-08-26T00:00:00.000Z
- Discovered by monitor: 2026-08-26T22:31:21.349Z
Published from the regulator source ingestion pipeline after PV impact triage.
