Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Boston Scientific Corporation has initiated a Class I recall of the ENROUTE Transcarotid Neuroprotection System due to potential arterial sheath tip separation.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 9, 2026 and geographically references United States. The FDA classifies this as a Class I recall, with the stated reason "Potential for arterial sheath tip separation or partial tip separation during use.", distributed worldwide distribution: us (nationwide) and ous (foreign) to countries of: australia, canada, china, jamaica. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Boston Scientific Corporation is recalling the ENROUTE Transcarotid Neuroprotection System because of the potential for arterial sheath tip separation or partial tip separation during use.
Which Products Are Affected
The recall involves the Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter. A total of 115,458 units are affected. The product has GTIN 00811311020829 and includes numerous lot numbers distributed worldwide, including nationwide in the United States and to Australia, Canada, China, and Jamaica.
What You Should Do
Consumers and healthcare providers should follow instructions provided in the firm's notification letter regarding the recalled devices.
Why This Matters
This is a Class I recall, indicating a situation in which there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.
Source
FDA recall number Z-2977-2026. Recalling firm: Boston Scientific Corporation, Maple Grove, MN.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,084 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to September 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.