Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Summary
The FDA issued a Class I for Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Nu by Boston Scientific Corporation. Reason: Potential for arterial sheath tip separation or partial tip separation during use..
Details
Source
Device Recall
External ID
Z-2978-2026
Action Date
2026-08-26
Status
Ongoing
Category
device
Product Description
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Lot/Code Info: GTIN 00811311021062, Lot Numbers: 305737, 305738, 305913, 305929, 305940, 306079, 306085, 306093, 306097, 306115, 306168, 306178, 306187, 306195, 306200, 306207, 306219, 306232, 306242, 306244, 306272, 306279, 306290, 306305, 306311, 306319, 306320, 306328, 306338, 306348, 306359, 306372, 306391, 306408, 306420, 306431, 306440, 306453, 306460, 306473, 306478, 306508, 306523, 306546, 306555, 306568, 306579, 306589, 306626, 306636, 306645, 306662, 306691, 306713, 306731, 306745, 306754, 306776, 306787, 306795, 306806, 306834, 306862, 306867, 306871, 306876, 306894, 306896, 306905, 306913, 306921, 306935, 306950, 306956, 306963, 306978, 306989, 307005, 307009, 307036, 307040, 307048, 307066, 307091, 307101, 307111, 307113, 307124, 307138, 307148, 307157, 307174, 307185, 307195, 307207, 307215, 307226, 307236, 307246, 307256, 307259, 307265, 307282, 307285, 307299, 307304, 307311, 307321, 307346, 307351, 307354, 307355, 307356, 307357, 307358, 307361, 305736-2.
Quantity Affected: 49,229 units
Reason for Recall
Potential for arterial sheath tip separation or partial tip separation during use.
Distribution
Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-09
Company
Maple Grove, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 149 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Boston Scientific Corporation has 424 FDA actions in our database, including 355 recalls and 69 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 424 FDA actions in our database, including 355 recalls and 69 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2978-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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