WECK IPN002004Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 34026704410232), received between Jun 6, 2023 and Jun 6, 2023 — classified as 1 malfunction.

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

• MalfunctionJun 6, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  THE COMPLAINT IS REPORTED AS: "(B)(6) 2023, CARTRIDGE WAS FOUND BROKEN DURING INCOMING INSPECTION." NO PATIENT INVOLVEMENT. UPON INSPECTION OF THE RETURNED DEVICE AT THE INVESTIGATION SITE, IT WAS DISCOVERED THAT THE PACKAGE WAS ACTUALLY PUNCTURED AND THE STERILITY WAS COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070784 ↗

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