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The U.S. Food and Drug Administration (FDA) is aware that Boston Scientific has issued a letter to affected customers recommending certain Percutaneous Catheter be removed from where they are used or sold. Boston Scientific is recalling specific lots of ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus due to reports of arterial sheath tip separation or partial tip separation during use.
Tip separation may require endovascular or surgical retrieval of the retained tip. Complications associated with a retained tip include embolism, stroke, transient ischemic attack, restenosis, or thrombosis.
As of July 9, Boston Scientific has reported one serious injury and no deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Boston Scientific at BSCFieldActionCenter@bsci.com or call (763) 415-7708.
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