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Boston Scientific ENROUTE Transcarotid Neuroprotection… recallZ-2978-2026 · Boston Scientific Corporation · initiated Jul 9, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

Boston Scientific issued an "Urgent Medical Device Removal" notice to its consignees on 7/9/2026 via FedEx. The notice explained the issue, potential risk, and requested the following actions to be taken: 1. Immediately discontinue use and segregate Affected Product. 2. Complete and return the Reply Verification Tracking Form (RVTF) to get a Return Goods Authorization (RGA) number. " Indicate the quantity of SINGLE units you will be returning for credit " If you have product that is listed and not included on your RVTF, provide the material number, lot number, and quantity you intend to return on your RVTF and return via: Email: [email protected] or Fax: BSC Field Action Center 1-763-415-7708. This Removal Notice must be completed and returned even if you do not have any Affected Product. 3. Once Boston Scientific receives your completed RVTF, you will be contacted and given an RGA number for product return. Package and ship affected product: " Write the RGA number in large print on the enclosed (red/white) return address label " Affix the return address label to the outside of box " Use our Federal Express account number: 9205-2515-6 to return package via second-day delivery "Seal box and return to: Boston Scientific Corporation, US Distribution, Center, 500 Commander Shea Blvd, Quincy, MA 02171 Credit will be issued for all returned Affected Product. 5. If you have sent a response to this Removal Notice to anyone other than Boston Scientific, we would not have received your response. Please ensure response is sent to email or fax indicated above. Forward this notice to relevant personnel and any facilities to which the product was transferred. 6. Continue to follow the standard of practice. If you require additional information regarding this recall, please contact your local Boston Scientific representative or the Sr. Quality Manager at 793.494.1133.

Recall details

Recall number
Z-2978-2026
Status
Open, Classified
Initiated by the company
Jul 9, 2026
Posted by the FDA
Aug 20, 2026
Recalling firm
Boston Scientific Corporation
Quantity
49,229 units
Product code
NTE
FDA submissions
K230402
Distribution
Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica

Product description

Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 99454).

Sources and updates

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