Recall Notice: Weck Hem-o-Lok Ligating Clips: Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy

On May 6, 2011, The FDA notified health care providers that Weck Hem-o-Lok Ligating Clips should not be used for the ligation of the renal artery during a laparoscopic living-donor nephrectomy because of serious risks to the donor. There is the potential for the clips to become dislodged, which can lead to uncontrolled bleeding, additional surgery, or death of the donor. In 2006, the manufacturer added this contraindication to the Instructions for Use after receiving 15 reports of 12 injuries and three deaths which occurred between 2001 and 2005. Since the contraindication issued in 2006, there have been three more kidney deaths, all associated with the contraindicated use. The Weck Hem-o-Lok Ligating Clip is a V-shaped clip made from a non-absorbable material that comes in various sizes. It is used to permanently close bleeding vessels or tissue structures. See the FDA safety communication for a listing of affected model numbers, and recommendations for healthcare providers, hospital staff, and patients. Click here for more information.