Terumo CVS Recalls Pediatric Arterial Cannulae
Terumo Cardiovascular Systems (Terumo CVS) is issuing 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 U.S., 734-663-4145. Contact can be made Monday-Friday from 8:00 a.m. to 5:00 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.