WECK IPN028174Recalls & reported problems
Teleflex Incorporated · HORIZON TI MICRO 6 Clips/Cart · Class 2 · Implant
All models of WECK (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 34026704624844), received between Mar 1, 2022 and Jul 29, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Activation Failure” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Failure2
- Failure to Form Staple1
- Positioning Problem1
Patient problems
- Hematoma2
- Hemorrhage/Blood Loss/Bleeding2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Tissue Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT "DURING SURGERY THE SURGEON NOTICED X 2 STRAY CLIPS FLOATING IN THE PATIENT THAT HAD COME LOOSE FROM BEING LIGATED ONTO A VESSEL. PATIENT CHECKED FOR ANY AREAS OF BLEEDING, NONE FOUND, CASE CONTINUED". NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22645424 ↗InjuryJul 11, 2022Activation Failure; Activation Failure
DURING LIGATION OF ABDOMINAL FLAP VESSELS AND PEDICLE THE CLIPS LACERATED THE VESSEL. THIS HAPPENED SEVERAL TIMES DURING THE PROCEDURE. THE CLIPS CARTRIDGES WERE THEN CHANGED TO CARTRIDGES FROM A NEW BATCH AND THE PROBLEM DID NOT REPEAT. THE PATIENT SUBSEQUENTLY DEVELOPED A LARGE HAEMATOMA AND THE CASE TOOK 2 HOURS LONGER THAN SCHEDULED. THERE WERE 5 DEFECTIVE CARTRIDGES INVOLVED IN THE EVENT. ALL 6 CLIPS FROM EACH CARTRIDGE WERE USED. MEDICAL INTERVENTION: VESSELS HAD TO BE TIED AND DIATHERMIED, SLOWING THE PROCEDURE DOWN AS SURGEONS TRIED TO MANAGE THE BLEEDING.
Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding
MAUDE report 14982208 ↗InjuryJul 11, 2022Activation Failure; Activation Failure
DURING LIGATION OF ABDOMINAL FLAP VESSELS AND PEDICLE THE CLIPS LACERATED THE VESSEL. THIS HAPPENED SEVERAL TIMES DURING THE PROCEDURE. THE CLIPS CARTRIDGES WERE THEN CHANGED TO CARTRIDGES FROM A NEW BATCH AND THE PROBLEM DID NOT REPEAT. THE PATIENT SUBSEQUENTLY DEVELOPED A LARGE HAEMATOMA AND THE CASE TOOK 2 HOURS LONGER THAN SCHEDULED. THERE WERE 5 DEFECTIVE CARTRIDGES INVOLVED IN THE EVENT. ALL 6 CLIPS FROM EACH CARTRIDGE WERE USED. MEDICAL INTERVENTION: VESSELS HAD TO BE TIED AND DIATHERMIED, SLOWING THE PROCEDURE DOWN AS SURGEONS TRIED TO MANAGE THE BLEEDING.
Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding
MAUDE report 14982188 ↗InjuryMar 1, 2022Positioning Problem; Positioning Problem
WHEN CLOSING VESSEL WITH MICROCLIP THE VESSEL WAS CUT. THE PATIENT'S CONDITION OR INTERVENTION IS UNKNOWN.
Patient problems: Insufficient Information; Unspecified Tissue Injury
MAUDE report 13636322 ↗
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 · TerminatedHorizon 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
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- Endo Clip III 176630Covidien LP · CLIP, IMPLANTABLE1 death1,959 reports
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- LIGACLIP ER320Ethicon Endo-Surgery, LLC · CLIP, IMPLANTABLE1,115 reports
- Direct Drive® Clip Applier CA090Applied Medical Resources Corporation · Clip, Implantable1 death806 reports
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- Endo Clip 176625Covidien LP · CLIP, IMPLANTABLE1 death768 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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