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WECK IPN028170Recalls & reported problems

Teleflex Incorporated · HORIZON TI SMALL RED 6 Clips/Cart · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 34026704624752), received between May 4, 2023 and May 4, 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

Device problems

  • Delivered as Unsterile Product1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionMay 4, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

    THE REPORT STATES THAT DURING PRIOR TO USE IN THE CLINICAL SETTING "WHEN STAFF TRIES TO TAKE THE CLIPS USING THE CLIP APPLIER, PIECES OF THE PLASTIC ARE ATTACHED TO IT AND THEY HAVE SEEN IT ON THE SURGICAL SITE". ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER STATES THAT THEY ARE "PRIMARILY FINDING ON STERILE FIELD AND HAVING TO BREAK DOWN MID PROCEDURE DUE TO THE WHITE PLASTIC FROM THE MECHANISM THAT HOLDS THE CLIPS IN PLACE PRIOR TO LOADING". PER THE CUSTOMER, THERE IS NO PATIENT INVOLVEMENT AS THE PARTICULATES ARE FOUND PRIOR TO PATIENT USE WHEN THE SURGEON IS READY TO UTILIZE THE APPLIER ON THE PATIENT.

    Patient problems: Insufficient Information

    MAUDE report 16868164 ↗

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

Other CLIP, IMPLANTABLE devices

All CLIP, IMPLANTABLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.