Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus recall (Boston Scientific Corporation)
Medical deviceClass IOngoing
Summary: Boston Scientific Corporation is recalling Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter. Reason: Potential for arterial sheath tip separation or partial tip separation during use.
What is being recalled
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Why
Potential for arterial sheath tip separation or partial tip separation during use.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2978-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | July 9, 2026 |
| Reported | August 26, 2026 |
| Company | Boston Scientific Corporation |
| Company location | Maple Grove, MN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 49,229 units |
More recalls from Boston Scientific Corporation · all medical device recalls · recalls from July 2026