Terumo Cardiovascular Systems Issues Recall of Pediatric Arterial Cannulae -- Occupational Health & Safety

Terumo Cardiovascular Systems Issues Recall of Pediatric Arterial Cannulae

Dec 10, 2008

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:

Online: www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178

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