Class I Recall Issued for Terumo Coronary Ostia Cannula

The FDA has issued a Class I recall for Terumo Cardiovascular Systems’ coronary ostia cannula as foreign fragments of adhesive and plastic in the cannula tip may embolize causing arterial injury, hemorrhaging or other serious events requiring unplanned surgery. More than 6,000 devices are subject to the recall. The product line was removed from the market.