Weck Hem-o-Lok Ligating Clips Are Contraindicated for Ligation of Renal Artery during Laparoscopic Living-Donor Nephrectomy

Urologists, Transplant Surgery healthcare personnel and Risk Managers are warned by the FDA 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 this poses serious risks to the donor.

Background of Weck Hem-o-Lok Ligating Clips

The Weck Hem-o-Lok Ligating Clip is a V-shaped clip used to permanently close bleeding vessels or tissue structures. It is manufactured from a non-absorbable material coming in various sizes. FDA Alert on Weck Hem-o-Lok Ligating Clips

FDA warns that Weck Hem-o-Lok Ligating Clips may become dislodged and uncontrolled bleeding may occur, leading to additional surgery, and/or death of the kidney donor. Weck Hem-o-Lok Ligating Clips are contraindicated for ligation of the renal artery during laparoscopic living-donor nephrectomies.

The affected clips and model numbers are: 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) and Weck Endo5 Hem-o-Lok Medium Large (ML) Automatic Endoscopic Applier (543965).

Recommendation on Weck Hem-o-Lok Ligating Clips

“See the FDA safety communication for a listing of affected model numbers, and recommendations for healthcare providers, hospital staff, and patients.”

Contacting the FDA to report cases with Weck Hem-o-Lok Ligating Clips

The following information, if available, would be helpful in reports to the FDA:

• Manufacturer’s Name
• Device Name (Brand Name)
• Date Device was Manufactured
• Distributor’s Name
• Details of Adverse Event and Medical and/or Surgical Interventions (if required)

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