Device recall

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

FDA recall source

Recall number

Z-2977-2026

Event id

99454

Status

Ongoing

FDA classification

Class I

Recalling firm

Boston Scientific Corporation

Report date

Aug 26, 2026

Posted

Aug 20, 2026

Initiated

Jul 9, 2026

Center classification date

Aug 20, 2026

Product code

NTE

Device type

Temporary Carotid Catheter For Embolic Capture

Reason

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

Root cause

Under Investigation by firm

Quantity

115,458 units

Code info

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.

Distribution

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

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K153485

Location

Maple Grove, MN, United States