FDA · Class I · August 26, 2026

Boston Scientific recall: ENROUTE Transcarotid Neuroprotection System and 1 more product

Boston Scientific Corporation is recalling Boston Scientific ENROUTE Transcarotid Neuroprotection System and 1 more product – 115,458 units; 49,229 units. The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on July 9, 2026. Distributed nationwide.

Most serious Class I is the most serious level: a reasonable probability that using or eating the product will cause serious health problems or death.

Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.

Product	Boston Scientific ENROUTE Transcarotid Neuroprotection System and 1 more product
Brand	Boston Scientific
Company	Boston Scientific Corporation
Type	Medical devices
Classification	Class I
Recall date	July 9, 2026
Published by FDA	August 26, 2026
Quantity	115,458 units; 49,229 units
Recall ID	99454

As listed by FDA

Recalled products (2)

Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
FDA recall number
Z-2977-2026
Codes, lots and dates
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.
Quantity
115,458 units
Classification
Class I
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
FDA recall number
Z-2978-2026
Codes, lots and dates
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
49,229 units
Classification
Class I

Exactly as the agency lists them

Identifiers and details

FDA event ID: 99454
Initiated: Voluntary: Firm initiated
Status: Ongoing
Firm location: Maple Grove, MN, United States

Why it was recalled

The reason the FDA lists: “Potential for arterial sheath tip separation or partial tip separation during use.”

Where it was sold

Nationwide. Distribution as the FDA records it: “Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99454, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

Same brand

Other Boston Scientific recalls

Date	Recall	Problem	Agency
Sep 30, 2026	Boston Scientific recall: Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5Medical devices · 262,686	Tip may fracture or detach, leading to device fragments remaining within the patient or mi… Most serious	FDA Class I
Sep 23, 2026	Boston Scientific recall: Corporation StoneSmart Connect Console Contents:Medical devices · 982 units	A subset of power adapters used with the connect console may exhibit higher-than-expected … Serious	FDA Class II
Sep 9, 2026	Boston Scientific recall: LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS…Medical devices · N/A	There is potential for a delay in AF Burden Alert notification affecting the server softwa… Serious	FDA Class II
Aug 26, 2026	Boston Scientific recall: OverStitch Suture Cinch and 1 more productMedical devices · 60,654 units	Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. Serious	FDA Class II

All 5 Boston Scientific recalls →

FAQ

About this recall

Is Boston Scientific Boston Scientific ENROUTE Transcarotid Neuroprotection System recalled?

Yes. Boston Scientific Corporation recalled it on July 9, 2026; FDA published it August 26, 2026 (Class I). Only the lots, dates or models listed on this page are included.

Why was it recalled?

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

What should I do if I have it?

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.