WECK IPN028169Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 34026704624745), received between Jun 8, 2022 and Nov 2, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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.

• InjuryNov 2, 2023Device Fell; Device Fell

  IT WAS REPORTED THAT "BLEEDING OCCURRED FROM THE DURA MATER DURING MICRONEUROVASCULAR DECOMPRESSION AT NEUROSURGERY. HE/SHE USED THE CLIP TO STOP THE BLEEDING AND COMPLETED THE SURGERY WITHOUT PROBLEM. AT THE FOLLOW-UP THE NEXT DAY, THE PHYSICIAN FOUND THAT THE CLIP FELL ON THE CREASE OF THE CEREBELLUM. NO HEALTH CONSEQUENCE TO THE PATIENT OCCURRED". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057664 ↗
• MalfunctionJul 11, 2022Activation Failure; Activation Failure

  CLIPS WILL NOT STAY LOADED ON APPLIERS. 3 APPLIERS TRIED WITH FAILURE. NEW LOT' WORKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983165 ↗
• InjuryJun 8, 2022Difficult to Open or Close; Difficult to Open or Close

  DURING USE OF THE DEVICE THE CLIPS DO NOT HOLD AND JUMP OFF (REOPENED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633439 ↗

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