Z-2977-2026Class I

Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous...

Name: Z-2977-2026 Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous...
Creator: Boston Scientific Corporation
Published: 2026-07-09
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-07-09 / Open, Classified

FDA source

Boston Scientific Corporation began a recall of Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter on 2026-07-09. FDA classified it as Class I and gives the reason as "Potential for arterial sheath tip separation or partial tip separation during use". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2977-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-07-09
Posted: 2026-08-20
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Product code: NTE Temporary Carotid Catheter For Embolic Capture
Reason for recall: Potential for arterial sheath tip separation or partial tip separation during use.
FDA 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: [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.
Quantity in commerce: 115,458 units
Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2977-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2977-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-20
Z-2978-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-20

Product code NTE

K153485Class IIENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc. / cleared 2016-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)