Terumo Cardiovascular Systems Issues Recall of Pediatric Arterial Cannulae

Terumo Cardiovascular Systems (Terumo CVS) has issued an urgent, nationwide/worldwide recall of its Tenderflow™ Pediatric Arterial Cannulae involving 21 lot codes.

Terumo received 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. There have been no reports of patient injury or death associated with the product.

Tenderflow™ Pediatric Arterial Cannula Catalog and Lot Numbers Affected

Catalog Number

Lot Number

813568

0501639, 0512002

813567

0501557, 0512008

813570

0502200, 0513069

813569

0502199, 0513068, 0517852

813572

0507121, 0512918

813571

0507120, 0512919, 0518680

813574

0509240

813573

0509238, 0517874

813576

0509241

813575

0500759, 0513331

813578

0500760

813577

0502878

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. The notification letter recommended that customers not use the product unless medically necessary. In those cases, the cannula should be used without the introducer. Clinicians with questions may contact the company at 800-521-2818, or if calling from outside the United States, 734-663-4145. Contact can be made Monday-Friday from 8 a.m. to 5 p.m. EST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax:

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