The US FDA is recommending that certain lots of Boston Scientific's ENROUTE Transcarotid Neuroprotection System percutaneous catheters be avoided following reports of arterial sheath tip separation or partial tip separation. The company has reported one serious injury since July 9. The agency warned that tip separation may require endovascular or surgical retrieval of the retained tip, and complications can include embolism, stroke, transient ischemic attack, restenosis, or thrombosis.
Boston Scientific CorpFDA warns against certain lots of Boston Scientific's ENROUTE catheters due to tip separation risk, with one serious injury reported.
Advanced Micro Devices Inc