Use caution Medical device recall · FDA · Published July 9, 2026

Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus: Risk of Arterial

Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System Plus (Material Number SR-250-NPS) due to potential arterial sheath tip separation during use. Affected units include specific lot numbers and GTIN.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2978-2026Medical device Boston Scientific ›

Use caution until it’s fixed

Potential for arterial sheath tip separation or partial tip separation during use.

✎ GovInfoNow plain-language explainer

Boston Scientific is recalling its ENROUTE Transcarotid Neuroprotection System Plus catheter (Material Number SR-250-NPS) because it may separate during use, potentially causing complications. This recall affects medical devices used in certain surgical procedures. Read more at govinfonow.com/recall/697920-boston-scientific-enroute-transcarotid-neuroprotection-system-plus-risk-of-arterial.

Source Summary by GovInfoNow · govinfonow.com/recall/697920-boston-scientific-enroute-transcarotid-neuroprotection-system-plus-risk-of-arterial · Updated September 14, 2026 · FDA enforcement record: FDA #Z-2978-2026

Cite this page

“Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus: Risk of Arterial.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697920-boston-scientific-enroute-transcarotid-neuroprotection-system-plus-risk-of-arterial. Based on FDA recall #Z-2978-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2978-2026%22&limit=1).

The FDA announced on July 9, 2026, that Boston Scientific Corporation is recalling the ENROUTE Transcarotid Neuroprotection System Plus percutaneous catheters due to a potential arterial sheath tip separation hazard. The agency issued recall number Z-2978-2026 for the Class I voluntary recall affecting 49,229 units distributed worldwide.

How to tell if you have it

Brand: Boston Scientific
Product: ENROUTE Transcarotid Neuroprotection System Plus; Percutaneous catheter
Material Number: SR-250-NPS
UPC: 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
Units Affected: 49,229

The hazard

According to the FDA, the recall addresses the potential for arterial sheath tip separation or partial tip separation during use of the device. The agency classified this as a Class I recall, indicating a situation where use could cause serious adverse health consequences or death.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent brand recalls include the Aug. 24, 2026, Imager II Angiographic Catheters recall for tip fracture risk and the Aug. 6, 2026, LUX-Dx Cardiac Monitor System recall for delayed AF burden alerts. Other recent recalls of similar products include the June 26, 2026, Boston Scientific Transcarotid Kit Sheath Depth Markings Detachment recall and the May 22, 2026, Medtronic Harmony Catheter System recall for tip detachment risk.

How to tell if you have this one

Check for Material Number SR-250-NPS on the device. Affected units include specific lot numbers listed in the recall and GTIN 00811311021062.

Brand
Boston Scientific
Product
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica

Recall number	Product, codes & lots	Quantity
Z-2977-2026	Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter; GTIN 00811311020829, Lot Numbers: 200832, 200850, 201057, 201070, 201087, 201113, 201128, 201143, 201157, 201177, 201190, 201220, 201235, 201312, 201333, 201351, 201379, 201407, 201422, 201487, 300015, 300028, 300043, 300058, 300075, 300099, 300114, 300135, 300143, 300154, 300168, 300188, 300203, 300213, 300229, 300252, 300262, 300271, 300311, 300325, 300346, 300358, 300377, 300395, 300404, 300418, 300430, 300445, 300471, 300492, 300520, 300532, 300545, 300559, 300566, 300581, 300600, 300613, 300630, 300664, 300679, 300680, 300690, 300697, 300751, 300775, 300781, 300782, 300800, 300802, 300818, 300844, 300861, 300867, 300874, 300879, 300898, 300904, 300917, 300925, 300932, 300944, 300952, 300977, 300989, 301005, 301007, 301022, 301036, 301051, 301077, 301091, 301115, 301136, 301184, 301229, 301232, 301234, 301235, 301276, 301277, 301278, 301290, 301328, 301336, 301355, 301376, 301385, 301400, 301418, 301435, 301443, 301457, 301464, 301476, 301487, 301535, 301550, 301565, 301596, 301626, 301636, 301644, 301660, 301722, 301739, 301750, 301761, 301771, 301779, 301792, 301811, 301831, 301844, 301871, 301880, 301901, 301923, 301935, 301945, 301958, 301975, 301991, 302016, 302033, 302049, 302058, 302115, 302135, 302154, 302162, 302166, 302176, 302182, 302187, 302200, 302221, 302234, 302250, 302267, 302298, 302310, 302326, 302337, 302340, 302353, 302366, 302376, 302394, 302403, 302423, 302459, 302471, 302484, 302494, 302500, 302510, 302527, 302540, 302550, 302568, 302585, 302596, 302621, 302648, 302657, 302668, 302676, 302688, 302714, 302726, 302728, 302737, 302749, 302758, 302766, 302785, 302789, 302807, 302832, 302845, 302862, 302868, 302895, 302917, 302918, 302926, 302944, 303020, 303027, 303035, 303047, 303052, 303063, 303082, 303088, 303100, 303119, 303129, 303130, 303147, 303154, 303160, 304001, 304038, 304044, 304128, 304129, 304142, 304147, 304203, 304215, 304237, 304251, 304261, 304276, 304285, 304300, 304323, 304327, 304336, 304344, 305002, 305004, 305036, 305051, 305065, 305082, 305084, 305117, 305135, 305141, 305143, 305160, 305180, 305194, 305230, 305247, 305258, 305269, 305275, 305286, 305313, 305340, 305344, 305366, 305396, 305404, 305432, 305449, 305470, 305484, 305522, 305548, 305571, 305573, 305592, 305611, 305632, 305639, 305673, 305693, 305711, 305719, 305735, 305756, 305799, 305808, 305826, 305835, 305849, 305873, 305885, 305892, 305949, 305967, 305979, 305987, 306009, 306017, 306034, 306045, 306071, 306077, 306116, 306117, 306126, 306129, 306134, 306141, 306146, 306156, 306260, 306697, 306715, 306726, 304051-2, 304056-2, 304057- 2, 304058-2, 304154-2, 304168-2, 304169-2, 304182-2, 304186-2, 304190-2, 304259-2.	115,458 units
Z-2978-2026	Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter; 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.	49,229 units

Based on the official FDA remedy

What to do — step by step

Check Device Details
Look for Material Number SR-250-NPS and the listed lot numbers on the device.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 48 days after the firm started it.

Jul 9, 2026Firm started the recall
Aug 20, 2026FDA classified it Class I
Aug 26, 2026Published in FDA’s Enforcement Report
Sep 8, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/697920-boston-scientific-enroute-transcarotid-neuroprotection-system-plus-risk-of-arterial">Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus: Risk of Arterial (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2978-2026 (July 9, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2978-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.