MEDICAL DEVICE RECALLCRITICAL

ENROUTE Transcarotid Neuroprotection System

Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System over sheath tip separation risk.

What to do

Do not use the ENROUTE Transcarotid Neuroprotection System. Contact Boston Scientific for instructions on returning the device and for further guidance.

Recalled

2026-07-09

Listed

2026-08-20

Updated

2026-08-21

Recall No.

Z-2977-2026

Agency

FDA

Firm

Boston Scientific Corporation

Recall ID

99454

Status

ONGOING

Why it was recalled

Boston Scientific is recalling the ENROUTE Transcarotid Neuroprotection System, a percutaneous catheter, due to the potential for arterial sheath tip separation or partial tip separation during use. This may lead to serious patient harm.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Boston Scientific ENROUTE Transcarotid Neuroprotection

Product	Lot code	Recall #	UDI-DI
System, Material Number SR-200-NPS; Percutaneous catheter	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 (+287 more, see the official notice)	Z-2977-2026	00811311020829
System Plus, Material Number SR-250-NPS; Percutaneous catheter	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 (+77 more, see the official notice)	Z-2978-2026	00811311021062

Where it was sold

Distributed nationwide.

Timeline

2026-07-09Firm initiated recall
2026-08-20Publicly announced
2026-08-21Listed on Recall Canary
2026-08-21Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-08-21 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification