FDA recall, , High risk
Boston Scientific ENROUTE Transcarotid Neuroprotection System
The ENROUTE Transcarotid Neuroprotection System has a potential for arterial sheath tip separation during use.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation, of Maple Grove, Minnesota, recalled the Boston Scientific ENROUTE Transcarotid Neuroprotection System and the ENROUTE Transcarotid Neuroprotection System Plus, both percutaneous catheters, due to a potential for arterial sheath tip separation or partial tip separation during use.
The company began the recall on July 9, 2026, and the FDA added it to its Enforcement Report on August 20, 2026, with distribution nationwide and worldwide to Australia, Canada, China, and Jamaica.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
Incomplete list: 80 of 444 lot codes shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
- UDI-DI
- 00811311020829
- Lot code
- 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
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
- UDI-DI
- 00811311021062
- Lot code
- 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
Recall details
- Company began the recall
- Sold in
Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica
- Company
- Boston Scientific CorporationMaple Grove, Minnesota
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99454
- Recall numbers
- Z-2977-2026 to Z-2978-2026
All recalls from Boston Scientific Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
