WECK IPN914927Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 24026704696370), received between Jul 11, 2022 and Aug 8, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE "PATIENT UNDERWENT CHOLECYSTECTOMY PROCEDURE WITH CHOLANGIOGRAPHY BY VIDEOLAPAROSCOPY, BUT AFTER GOING TO THE UNIT, HE CONTINUED WITH SEVERE ABDOMINAL PAIN, DISTENSION, NAUSEA AND VOMITING. THE PATIENT MADE A THOMOGRAPHY SCAN OF THE ABDOMEN AND IT WAS IDENTIFIED THAT THE CLIPS HAD A SMALL AMOUNT OF FREE LIQUID, NEXT TO THE EMPTIED BED, IN THE ABDOMINAL CAVITY AND NOTABLY IN THE PELVIC REGION, AS WELL AS OBLITERATION OF ADJACENT FAT, RELATED TO PREVIOUS MANIPULATION. THERE WAS A NEED FOR SURGICAL REAPPROACH TO WHICH IT WAS IDENTIFIED THAT THE CLIP WAS OPEN". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS OR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 17481657 ↗
• MalfunctionMar 27, 2023Difficult to Open or Close; Difficult to Open or Close

  REPORTED ISSUE: PRODUCT IS NOT CLIPPING PROPERLY CAUSING EXCESSIVE USE OF CLIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16621453 ↗
• MalfunctionFeb 23, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  REPORTED ISSUE: IT WAS DETECTED ON RECEIPT THAT THERE WAS AN EMPTY CARTRIDGE UNIT AND AN OPEN CARTRIDGE UNIT. STERILITY WAS BREACH WITH THE OPEN UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432985 ↗
• MalfunctionJul 11, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THE DISTRIBUTOR DETECTED IN RECEIVING 1 UNIT WITH DAMAGED CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14980160 ↗

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