Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled the ENROUTE Transcarotid Neuroprotection System Plus (Material Number SR-250-NPS), a percutaneous catheter device. The recall affects 49,229 units distributed worldwide to the United States, Australia, Canada, China, and Jamaica. The reason for the recall is a potential for the arterial sheath tip to separate or partially separate during use of the device.
The recalled devices are identified by GTIN 00811311021062 and include numerous lot numbers ranging from 305736 through 307361. The recall document provided does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for arterial sheath tip separation or partial tip separation during use.
Reason for recall: Potential for arterial sheath tip separation or partial tip separation during use. Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica Quantity: 49,229 units Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.