Terumo Coronary Ostia Cannula
June 15, 2011 – The U.S. Food and Drug Administration (FDA) said Terumo Cardiovascular Systems Corp. has issued a class 1 recall for its Coronary Ostia Cannula 10 (25 cm) long. The company said foreign fragments of adhesive and plastic in the cannula tip may embolize, causing arterial injury, hemorrhaging or other serious events requiring unplanned surgery.
The FDA said Terumo decided to remove the product line from the market and discontinue further supply.
The recall involves 6,220 devices, with model numbers 804115, 804117, 804159, all lot/serial numbers. The Terumo Coronary Ostia Cannula is indicated for use in delivering cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass.
The company notified customers by letter May 16 describing the problem and the potential hazard.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
For more information: www.fda.gov/Safety/MedWatch/default.htm