On December 1, Terumo Cardiovascular Systems issued an urgent worldwide and nationwide recall of the company’s Tenderlow Pediatric Arterial Cannulaw. This recall included 21 lot codes.
Terumo, a company based in Ann Arbor, Michigan; Elkton, Maryland; Ashland, Massachusetts; and Tustin, California, is a marketer of medical devices and global manufacturer for cardiac and vascular surgery.
There were five reports explaining the difficulty retracting the introducer from the cannula. When this happens, the cannula must be removed and replaced. In this type of process, aortic damage, blood loss or death can occur.
The lot numbers can be found on the FDA website here:
Currently, there have been no reports of injury or death associated with this product.
What is an arterial cannula?
It is a disposable tube that is inserted in the aorta during many cardiac bypass surgery procedures.
Terumo distributed this product to 68 U.S. hospitals and to distribution centers in Australia, Canada and Europe. Customers are highly recommended to not use this product unless medically necessary. FDA recommends if it is necessary to use this product to do so without the introducer.
Please call the company’s # at 800-521-2818 with any questions.