The FDA and the Health Resources and Services Administration have sent out a joint alert telling 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.
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.
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The alert identifies specific Weck Hem-o-Lok ligating clips are contraindicated for ligation of the renal artery during laparoscopic living-donor nephrectomies because these clips may become dislodged, which can lead to uncontrolled bleeding, additional surgery, and/or death of the kidney donor.
Complications have occurred within hours of surgery.
The alert identifies the following clips (with model numbers):
- Weck Hem-o-Lok ML Medium Large Endo 5 (544230)
- Weck Hem-o-Lok L Large (544240)
- Weck Hem-o-Lok XL Extra Large (544250)
- Weck Endo5 Hem-o-Lok Medium Large (ML) Automatic Endoscopic Applier (543965)
The alert recommends urologists and kidney transplant surgeons not to use Weck Hem-o-Lok ligating clips for the ligation of the renal artery during laparoscopic living-donor nephrectomies and for hospital staff members to remind urologists, transplant surgeons and operating room staff that Weck Hem-o-Lok Ligating Clips should nOT be used for the ligation of the renal artery during laparoscopic living-donor nephrectomies because of the risk to living-donors.
Read the joint FDA/HRSA alert about Weck Hem-o-Lok ligating clips.
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