Terumo Cardiovascular Systems Issues Urgent, Nationwide/Worldwide Recall of 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 (see information below). 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.

* 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

Terumo informed the U.S. Food and Drug Administration of this recall. Terumo Cardiovascular Systems Corporation is a global manufacturer and marketer of medical devices for cardiac and vascular surgery. The company is headquartered in Ann Arbor, Michigan with manufacturing operations in Ann Arbor; Elkton, Maryland; Ashland, Massachusetts; and Tustin, California. For more information, visit www.terumo-cvs.com.

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