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Boston Scientific faces Class I recall for ENROUTE carotid devices

FDA · 2 days ago
BSX
Boston Scientific faces Class I recall for ENROUTE carotid devices
  • The recall covers certain ENROUTE Transcarotid Neuroprotection System and NPS Plus lots after reports of arterial sheath tip separation or partial separation during use.
  • A retained tip can require endovascular or surgical retrieval and is associated with embolism, stroke, transient ischemic attack, restenosis, or thrombosis.
  • Boston Scientific reported one serious injury and no deaths associated with the issue as of July 9.

Quotes

“The FDA has identified this recall as the most serious type.”— FDA
“Do not use affected product.”— FDA
“As of July 9, Boston Scientific has reported one serious injury and no deaths associated with this issue.”— FDA

Sources