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WECK IPN009040Recalls & reported problems

Teleflex Incorporated · HEMOLOK ML 6 Clips/Cart · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704601124), received between Feb 25, 2021 and Mar 22, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

  • Break2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 22, 2021Break; Break

    IT WAS REPORTED THAT A CLIP WAS FOUND BROKEN WHEN THE USER ATTEMPTED TO LOAD IT DURING A PRETEST. ACCORDING TO THE USER, IT WAS UNKNOWN WHETHER THE CLIP HAD BEEN BROKEN BEFORE LOADING OR IT GOT BROKEN AT LOADING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11544447 ↗
  • MalfunctionFeb 25, 2021Break; Break

    IT WAS REPORTED THAT A CLIP GOT BROKEN WHEN THE USER ATTEMPTED TO LOAD IT DURING A SURGERY, ALTHOUGH HE/SHE DID NOT APPLY ANY EXCESSIVE PRESSURE/FORCE. NO CLIP FELL/REMAINED IN THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11378898 ↗

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.