fda-safety ·
Early alert for possible catheter tip separation with ENROUTE system
FDA safety alert says Boston Scientific ENROUTE Transcarotid Neuroprotection Systems may experience partial or complete arterial sheath tip separation during use.
If you are having a procedure that uses an ENROUTE Transcarotid Neuroprotection System, Food and Drug Administration (FDA) says there may be an issue where the arterial sheath tip separates or partially separates during use.
A separated tip means the catheter’s tip may not stay intact as intended during the procedure, which could affect how the device works.