Boston Scientific ENROUTE system recalled over sheath tip separation
Boston Scientific is recalling certain ENROUTE Transcarotid Neuroprotection System units (Material Number SR-200-NPS) because the arterial sheath tip may separate or partially separate during use. The recall covers 115,458 units across many lot numbers, distributed in the US and to Australia, Canada, China, and Jamaica. No injuries have been reported, and the FDA classified the recall as Class I, its most serious category.
From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls
What to do
- Check inventory for Material Number SR-200-NPS (GTIN 00811311020829) and the listed lot numbers.
- Contact Boston Scientific for guidance on any affected units before using them.
- Follow your facility's recall procedures to quarantine and return affected units.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 115,458 units
- Illnesses reported
- None reported
- Manufactured in
- 1 Scimed Pl, Maple Grove, MN, United States
- Classification
- Class I
- Recall number
- Z-2977-2026
In the FDA's words
- Description
- Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter Potential for arterial sheath tip separation or partial tip separation during use. 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 Affected quantity: 115,458 units
- Hazard
- Potential for arterial sheath tip separation or partial tip separation during use.
2 products in this recall
Boston Scientific ENROUTE devices recalled for tip separation risk
Boston Scientific is recalling two ENROUTE Transcarotid Neuroprotection System products: the standard system (Material Number SR-200-NPS) and the Plus system (SR-250-NPS). The recall covers about 164,700 units, distributed in the US and to Australia, Canada, China and Jamaica. The arterial sheath tip may separate, fully or partially, during use. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter (this page)Z-2977-2026 · 115,458 units
- Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheterZ-2978-2026 · 49,229 units
More from Boston Scientific
See all- Boston Scientific OverStitch Suture Cinch recalled for deployment and cutting failure risk
ModerateFDAAug 26, 2026