Tag: tip_separation

FDA Issues Early Alert for Boston Scientific ENROUTE System Recall

24 Jul 2026 3:44 p.m. · Source: US Food and Drug Administration

Boston Scientific is recalling specific lots of its ENROUTE Transcarotid Neuroprotection System and System Plus due to arterial sheath tip separation, which can lead to serious complications like stroke. The FDA has issued an Early Alert.

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