Recalled Terumo Tenderflow Pediatric Arterial Cannulae

Terumo Cardiovascular Systems (Terumo CVS) has issued an urgent, worldwide recall of all Tenderflow pediatric arterial cannulae with the lot codes shown below.

Terumo has already received five reports in which there was difficulty removing the “introducer” from the Tenderflow cannula. The cannula must be removed and replaced if an introducer can not be removed properly. This process may lead to aortic damage, blood loss and even death. The introducer stabilizes the cannula while it is being inserted, and is removed after insertion of the cannula.

The following Tenderflow pediatric arterial cannulae lot numbers by Terumo CVS have been recalled:

Terumo is advising health professionals not to use the product at all unless medically necessary, in which case they advise inserting the cannula without the introducer. For more information, health professionals should call Terumo’s hotline at 800-521-2818.

If you, a loved one or one of your patients has experienced problems with this product, you are urged to report it to the FDA Medwatch Adverse Event Reporting Program at www.FDA.gov/medwatch/how.htm .

Terumo CVS is a global manufacturer and marketer of medical devices for cardiac and vascular surgery. Terumo’s home offices are in Ann Arbor, MI.