WECK IPN915119Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 24026704696134), received between Nov 18, 2021 and Nov 18, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Align” (1 report).

1 other recall cover devices cleared under the same FDA submission (K132658); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2021Failure to Align; Failure to Align

  REPORTED EVENT: I WAS THE ONE USING THE HEMOCLIP APPLICATOR ON SATURDAY THE (B)(6). I NOTICED SEVERE BLEEDING FROM THE LEG THAT I HAD HARVESTED THE SAPHENOUS VEIN, ALTHOUGH I HAD ALREADY CLOSED IT AND IT LOOKED DRY. THAT AMOUNT OF BLEEDING I HAD NOT EXPERIENCED BEFORE ON A CLOSED LEG, LETTING ME WONDER HOW THIS HAPPENED. FIVE LIGAS HAD BEEN APPLIED ON THE STUMP OF THE SAPHENOUS VEIN. SAME NIGHT 2 LIGAS FROM THE VEIN BRANCH HAVE FALLEN AS WELL ON THE SAME PATIENT RESULTING TO CARDIAC ARREST, LOSS OF 2L OF BLOOD IN THE MEDIASTINUM AND 2 CYCLES OF CPR TO REVIVE THE PATIENT. THANKFULLY THE PATIENT SURVIVED WITHOUT SUFFERING ANY IMPAIRMENT. THE VEIN BRANCH AND THE STUMP WERE CLIPPED WITH THE SAME APPLICATOR. I BELIEVE 7 LIGAS HAVE FALLEN IN TOTAL WHICH DUE TO ITS RARITY MADE ME SUSPECT THE APPLICATOR. I RETRIEVED THE APPLICATOR WHICH BY MONDAY WAS ALREADY BACK STERILIZED READY TO BE USED IN CASE IT WAS THE REASON FOR ALL THIS AND SEND IT TO RLH FOR INSPECTION. THE PATIENT HAS NOW A SMALL HEMATOMA STARTING FROM THE STUMP ON THE AFFECTED LEG AND WOUND INFECTION. IN REGARDS TO PRODUCT ISSUES I TESTED THE APPLICATOR WHEN RETRIEVED IT AND WAS NOT DELIVERING CLOSED LIGAS CONSISTENTLY. THERE W

  Patient problems: Cardiac Arrest; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12837323 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132658. One submission often covers many models, so check the product and lot details in each record.

• Z-1663-2023 · Apr 28, 2023 · Open, Classified
  Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation