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

Recall number

Z-2978-2026

Recalling firm

Boston Scientific Corporation

Product

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

Status

Open, Classified

Initiated

2026-07-09

Posted

2026-08-20

Terminated

not on file

Reason

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

Root cause

Under Investigation by firm

Action

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: BSCFieldActionCenter@bsci.com 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.

Quantity

49,229 units

Distribution

Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica

Lot, serial or model codes

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.

510(k) numbers

["K230402"]

PMA numbers

not on file

Product code

NTE

Firm FEI

3002095335

Firm city

Maple Grove

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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