Primary source: What is a Medical Device Recall?
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.
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.
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.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
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.
Published from the regulator source ingestion pipeline after PV impact triage.
Review and verify that any cosmetic products sourced or distributed comply with the manufacturers listed in the updated QUEST system.
Annual reviews of new information will be conducted to update the summary, requiring continuous monitoring and data submission in response to findings.
Health professionals and stakeholders should review the safety signals linked to CAROTONE products in their signal management processes.
Marketing authorization holders (MAHs) must review and potentially update their product labeling to align with the new regulations by 11 April 2029 for products authorized before 11 May 2024.
