Terumo Coronary Ostia Cannula 10, 12, 14 Fr: Recall - Fragments of Adhesive and Plastic in the Cannula Tip May Embolize
MedSun: Newsletter #62, July 2011

FDA MedWatch Safety Alert

Foreign fragments of adhesive and plastic in the cannula tip may embolize causing arterial injury, hemorrhaging or other serious events requiring unplanned surgery. Terumo Cardiovascular Systems Corporation (Terumo CVS) decided to remove the product line from the market and discontinue further supply. Terumo is advising customers to immediately discontinue use of any affected product and return all products in inventory.

Additional Information:

FDA MedWatch Safety Alert. Terumo Coronary Ostia Cannula 10, 12, 14 Fr: Recall – Fragments of Adhesive and Plastic in the Cannula Tip May Embolize. June 14, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259082.htm


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