FDA issues early alert on Boston Scientific ENROUTE catheter tip separation risk
The CDRH has issued an Early Alert warning about a potential high risk issue with Boston Scientific's ENROUTE Transcarotid Neuroprotection System and its Plus version.
The problem involves possible separation of the arterial sheath tip or partial tip separation during use, prompting the company to advise customers to stop using the affected lots.
Boston Scientific sent a letter on July 9 instructing users to cease use, segregate the devices, return them to the manufacturer, and notify relevant staff and any downstream facilities.
The FDA is reviewing the situation and will update the public as more information becomes available.
This writeup was produced by pharmadog from original reporting by fda medwatch.
Original headline: “Early Alert: Percutaneous Catheter Issue from Boston Scientific”
read at fda medwatch ↗
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