December 9, 2008 - Terumo Cardiovascular Systems notified healthcare professionals of a worldwide recall of its Tenderflow Pediatric Arterial Cannulae involving 21 lot codes, after receiving five reports of difficulty retracting the introducer from the cannula.
When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death. The company and the FDA said healthcare professionals are advised to not use the product unless medically necessary. In those cases, the cannula should be used without the introducer. The company said there have been no reports of patient injury or death associated with the product.
An arterial cannula is a disposable tube inserted in the aorta during many cardiac bypass surgery procedures and is used to perfuse the ascending aorta. The cannula is inserted using an introducer, which stabilizes the cannula during insertion and is then removed.
Terumo CVS distributed this product directly to 68 U.S. hospitals, and has notified all of the hospitals of the voluntary recall in a letter dated Oct. 16, 2008. The product was also distributed from distribution centers in Australia, Canada and Europe.
Clinicians with questions may contact the company at (800) 521-2818, or if calling from outside the U.S., (734) 663-4145. Contact can be made Monday-Friday from 8 a.m. to 5 p.m. EST.
For more information: www.terumo-cvs.com