WECK IPN028165Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 34026704624776), received between May 4, 2022 and Feb 23, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

1 other recall cover devices cleared under the same FDA submission (K982313); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  REPORTED ISSUE: MULTIPLE CARDIAC POST-OP BLEEDS AS A RESULT OF LIGATING CLIPS COMING OFF ARTERIAL BRANCHES. THE PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16428381 ↗
• InjuryJun 14, 2022Positioning Failure; Positioning Failure

  THIS IS THE THIRD TIME THE SAME PLASTIC SURGEON AT (B)(6) HOSPITAL HAS HAD AN ISSUE WITH 001205 CLIPS LACERATING THE BLOOD VESSELS THEY ARE SUPPOSED TO BE LIGATING. THE SURGEON THEN HAS TO USE DIATHERMY TO SEAL THE VESSELS AS THE LACERATION CAUSES BLEEDING. THE CLIPS ARE USED IN TRAM FLAP RECONSTRUCTIONS ON POST MASTECTOMY PATIENTS AND ARE USED TO LIGATE ABDOMINAL VESSELS WHILE LIFTING THE FLAP.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14684709 ↗
• InjuryMay 4, 2022Leak/Splash; Difficult to Open or Close; Leak/Splash; Difficult to Open or Close

  SURGEON STATES CLIPS NOT CLOSING ON VESSEL, CAUSING VESSEL LEAK. ADDITIONAL INFORMATION: THE CLIPS WERE FOUND TO BE NOT CLOSING DURING A PROCEDURE, TRAM FLAP FOR BILATERAL MASTECTOMY. THE SURGEON DID NOT PERMIT BLEEDING TO CONTINUE; COULD HAVE BEEN SIGNIFICANT BUT WAS IMMEDIATELY IDENTIFIED AND CONTROLLED. NO ADDITIONAL PROCEDURE WAS NEEDED TO RESOLVE THE ISSUE. THE SURGEON USED DIATHERMY TO CONTROL THE BLEEDING. THE ISSUE OCCURRED WITH SEVERAL APPLIERS. THESE WERE THEN USED TO SUCCESSFULLY APPLY OTHER CLIPS. ALL APPLIERS USED IN THE CASE WERE ONLY REPLACED TWO WEEKS PRIOR AND WERE IN PERFECT WORKING ORDER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14282013 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K982313. One submission often covers many models, so check the product and lot details in each record.

• Z-2327-2016 · Aug 8, 2013 · Terminated
  Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic stru