Terumo Cardiovascular Systems (Terumo CVS) is issuing an urgent, worldwide recall of its Tenderflow Pediatric Arterial Cannulae, a device used in heart bypass surgery, after receiving five reports of difficulty retracting the introducer from the cannula - a disposable tube which, in this situation, is inserted in the aorta and is used to perfuse the ascending aorta.

Manufacturer working with FDA

The urgent worldwide recall is being conducted with the U.S. Food and Drug Administration (FDA), who says that 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.

Affected products

The following Tenderflow Pediatric Arterial Cannual Catalog and Lot Numbers are affected by the recall:

Catalog Numbers:                                         Lot Numbers:
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 

According to the FDA, the company distributed the products to 68 U.S. hospitals and has notified them of the recall. The product was also distributed from distribution centers in Australia, Canada and Europe. Although no injuries or deaths have been reported, the company recommends that customers not use the product unless medically necessary. In those cases, the cannula should be used without the introducer. For additional information, see the FDA's website at http://www.fda.gov/oc/po/firmrecalls/terumo12_08.html.

About the company

Terumo Cardiovascular Systems (Terumo CVS) is a company that develops and manufactures cardiac products. Its parent company is Terumo Corporation of Tokyo, Japan, a global medical products supplier. Its sister companies are Vascutek, Ltd., an artificial vascular grafts company and Terumo Heart, Inc., a developer of an implantable left ventricular assist device.