A device used in delivering a lifesaving cardioplegia solution to coronary arteries during cardiopulmonary bypass has been recalled, with consultation with the U.S. Food and Drug Administration, reports say.
The device, specified in reports as the Terumo Coronary Ostia Cannula, has evidently been responsible for depositing fragments of adhesive and plastic in the tip, which can cause arterial injury, reports say.
Terumo Cardiovascular Systems Corporation, of Ann Arbor, Michigan, removed the product line from the market and has apparently discontinued further supply. The recall was classified as a Class I recall by the FDA, which is the most serious type of recall. The company advises customers to immediately discontinue use of any affected product.
In addition, reports say health care professionals and consumers can report quality problems to FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch/report.htm.
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