Terumo CVS Pediatric Arterial Cannula Recall

December 2008

Terumo Cardiovascular Systems (Terumo CVS) has issued an urgent recall of 21 lots of its Tenderflow™ Pediatric Arterial Cannula. There is a potential for the medical devices to malfunction, which may lead to aortic damage, blood loss, and/or death.

Terumo has received five reports of proble ms retracting the introducer from the cannula. An arterial cannula is a disposable tube that is inserted in the aorta during many cardiac bypass surgeries. The cannula is inserted using an introducer, which stabilizes the cannula during insertion.

When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that can lead to serious injury and sometimes death. Terumo CVS distributed this product directly to 68 U.S. hospitals, and the company has notified all of the hospitals of the recall in a letter dated Oct. 16, 2008. The FDA's website lists all lots affected by the recall.