CLASS I ONGOING Device recall · Reported 26 Aug 2026 · FDA Enforcement Report

Enroute Transcarotid Neuroprotection System Plus recalled

Boston Scientific is recalling Enroute Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS, distributed nationwide in the US. The recall was initiated on 9 Jul 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesGTIN 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.

Quantity recalled49,229 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2978-2026
FDA event ID: 99454
Recalling firm: Boston Scientific, Maple Grove, MN
Classification: Class I
Status: Ongoing
Recall initiated: 9 Jul 2026
FDA classified: 20 Aug 2026
Reported: 26 Aug 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

9 Jul 2026	Recall initiated by company
20 Aug 2026	Classified by FDA	+42 days
26 Aug 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for arterial sheath tip separation or partial tip separation during use.

Product as listed by the FDA

Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter

Where it was distributed

Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica

Nationwide

Questions about this recall

Why was it recalled?

Potential for arterial sheath tip separation or partial tip separation during use.

Which lots are 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.

Where was it sold?

Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99454

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026	CLASS I	Enroute Transcarotid Neuroprotection System recalled	Boston Scientific	Other	Nationwide

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