Boston Scientific Corporation medical device recall: Boston Scientific ENROUTE Transcarotid Neuroprotection System
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99454
- Recall initiated
- Jul 9, 2026
- Classified by FDA
- Aug 20, 2026
- Posted in Enforcement Report
- Aug 26, 2026
- Recalling firm
- Boston Scientific Corporation
- Firm location
- Maple Grove, MN, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 2
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Potential for arterial sheath tip separation or partial tip separation during use.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jul 9, 2026. FDA classified it 42 days later, on Aug 20, 2026. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica Boston Scientific Corporation has 169 recalls in our records.
Recalled products (2)
Z-2977-2026 Class I Ongoing
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Codes / 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,…
Quantity: 115,458 units
Z-2978-2026 Class I Ongoing
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Codes / lots: 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,…
Quantity: 49,229 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 99454
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.