Boston Scientific Recalling Thousands of Percutaneous Catheters
MT Newswires Live
Yesterday
Boston Scientific (BSX) is recalling thousands of its percutaneous catheters due to possible arterial sheath tip separation that could lead to complications with a retained tip, the US Food and Drug Administration confirmed in a Wednesday statement.
The affected products are certain lots of the company's ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus devices, according to the statement. The FDA warned that potential complications include embolism and stroke, among others.
Boston Scientific has reported one serious injury related to the issue, the FDA said.
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