Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System after sheath tip separation reports
Boston Scientific announced a recall of its ENROUTE Transcarotid Neuroprotection System and the ENROUTE Transcarotid Neuroprotection System Plus.
The FDA classified the recall as the most serious type because the arterial sheath tip may separate during use, creating a risk of serious injury or death.
In a letter dated July 9, Boston Scientific instructed customers to immediately stop using the devices, segregate them, return them to the company, and notify relevant personnel.
Facilities are also advised to contact any other locations that may have received the affected lots and provide the same notice.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Percutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid Neuroprotection System”
read at fda medwatch ↗
comments(0)
5-min edit window · permanent after that