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WECK IPN008982Recalls & reported problems

Teleflex Incorporated · AUTO ENDO5 ML · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04026704600885), received between Mar 3, 2017 and Mar 3, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K021808); 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

  • Difficult to Remove1

Patient problems

  • Laceration(s)1

Recent adverse event reports

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

  • InjuryMar 3, 2017Difficult to Remove

    WECK HEM-O-LOK AUTO ENDO 5 CLAMPED BUT DEVICE WOULD NOT RELEASE FROM PT'S TISSUE. ADD'L CLAMPS HAD TO BE PLACED AROUND THIS DEVICE TO ALLOW IT TO BE DISSECTED AWAY FROM THE PT. THE SURGICAL PROCEDURE HAD TO BE CONVERTED TO OPEN REQUIRING A STAY IN THE HOSPITAL. REASON FOR USE: CHOLECYSTITIS.

    Patient problems: Laceration(s)

    MAUDE report 6383784 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021808. One submission often covers many models, so check the product and lot details in each record.

  • Z-0497-2020 · Oct 4, 2019 · Open, Classified
    WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-
  • Z-0159-2009 · Aug 22, 2008 · Terminated
    WECK Hem-o-lok Non-absorbable Polymer Ligation Clips, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. The use of the reusable Teleflex Medical metal ligating clips is transient
  • Z-0157-2009 · Aug 22, 2008 · Terminated
    Weck Hemoclip Plus Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and i
  • Z-0156-2009 · Aug 22, 2008 · Terminated
    Weck Hemoclip Traditional Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasi
  • Z-0160-2009 · Aug 22, 2008 · Terminated
    WECK HemoClip Auto, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the ap
  • Z-0158-2009 · Aug 22, 2008 · Terminated
    Weck , Horizon Titanium Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709, USA. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and int
  • Z-1099-06 · Apr 12, 2006 · Terminated
    Weck Hem-o-lok Endo 5 Automatic Clip Applier with Medium Polymer Ligating Clips; Rx, sterile, single use, disposable clip applier with medium size, non-absorbable polymer ligation

Other APPLIER, SURGICAL, CLIP devices

All APPLIER, SURGICAL, CLIP devices →

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