WECK IPN028280Recalls & reported problems
Teleflex Incorporated · HEM-O-LOK MEDIUM LARGE 5MM ENDOSCOPIC APPLIER · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Teleflex Hem-o-lok medium large endoscopic clip applier is a surgical tool that places small clips during keyhole surgery. Its 93 reports mostly describe clips that do not line up in the jaws, so they cannot load or fall off, and parts such as rivets popping out or tips bending during repair. Most reports say no patient was involved. No deaths or injuries are reported. No recalls name this device. Reports for the last 12 months (7) are fewer than in the previous 12 months (15).
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 93
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 34026704623625), received between Feb 9, 2021 and Apr 21, 2026 — classified as 93 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (59 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.
Reports received per month
Most reported problems
Device problems
- Failure to Align59
- Break13
- Material Deformation10
- Material Twisted/Bent6
- Detachment of Device or Device Component4
- Activation, Positioning or Separation Problem1
- Difficult to Open or Close1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions85
- Insufficient Information8
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Detachment of Device or Device Component
IT WAS REPORTED "A POPPED RIVET WAS IDENTIFIED DURING A REPAIR AT MSI." THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24941152 ↗MalfunctionApr 6, 2026Break
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793989 ↗MalfunctionApr 6, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793804 ↗MalfunctionFeb 24, 2026Failure to Align
IT WAS REPORTED THAT "CLIP FELL DUE TO JAW MISALIGNMENT." ADDITIONAL INFORMATION IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24433958 ↗MalfunctionFeb 17, 2026Failure to Align
IT WAS REPORTED THAT "APPLICATOR CANNOT LOAD THE CLIP DUE TO MISALIGNMENT IN JAW".
Patient problems: Insufficient Information
MAUDE report 24365194 ↗MalfunctionDec 17, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT "TIP BENT." MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN REQUESTED FROM THE COMPLAINANT HAVE BEEN UNS UCCESSFUL AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 23834203 ↗MalfunctionDec 3, 2025Break; Break
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 23708990 ↗MalfunctionOct 10, 2025Break; Break
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23268566 ↗MalfunctionOct 10, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23267224 ↗MalfunctionOct 10, 2025Break; Break
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23266284 ↗MalfunctionSep 25, 2025Failure to Align; Failure to Align
IT WAS REPORTED THAT DURING USE ON A LAPAROSCOPIC NEPHRECTOMY, THE JAWS OF THE APPLIER WERE MISALIGNED. THE PATIENT STATUS IS REPORTED AS "OK".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23147245 ↗MalfunctionSep 9, 2025Break; Break
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23007362 ↗MalfunctionSep 9, 2025Break; Break
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23007013 ↗MalfunctionAug 12, 2025Break; Break
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22785098 ↗MalfunctionAug 5, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22718764 ↗MalfunctionJul 15, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT "WHEN CLOSING THE APPLIER WITH A CLIP LOADED, THE CLOSURE SYSTEM (APPLIER'S HEAD) SEPARATED, MAKING IT IMPOSSIBLE TO APPLY THE CLIP. IT WAS IMPOSSIBLE TO REMOVE THE APPLIER FROM THE TROCAR, SO THE SURGEON HAD TO REMOVE THE TROCAR WITH THE APPLIER STILL INSIDE AND INSERT A NEW TROCAR. THE CLIP REMAINED IN THE JAWS OF THE APPLIER". NO REPORT OF PATIENT HARM OR INJURY.
Patient problems: Insufficient Information
MAUDE report 22509812 ↗MalfunctionJul 1, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22372890 ↗MalfunctionJun 5, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22153224 ↗MalfunctionJun 4, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22142274 ↗MalfunctionJun 3, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22133353 ↗MalfunctionMay 6, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT: "CLIPS NOT GETTING LOADED DUE TO JAWS OF APPLIER NOT FUNCTIONING PROPERLY." THE ISSUE WAS IDENTIFIED DURING PREPARATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21968959 ↗MalfunctionMar 17, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT "A POPPED RIVET WAS IDENTIFIED DURING REPAIR AT MSI". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21619901 ↗MalfunctionSep 13, 2024Failure to Align; Failure to Align
IT WAS REPORTED "IT WAS REPORTED THAT THE APPLIER JAWS WERE FOUND MISALIGNED BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD" NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20216827 ↗MalfunctionJul 31, 2024Failure to Align; Failure to Align
IT WAS REPORTED THAT THE APPLIER JAWS WERE FOUND MISALIGNED BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19879333 ↗MalfunctionJul 18, 2024Failure to Align; Failure to Align
IT WAS REPORTED THAT "THE JAWS GOT MISALIGNED DURING A SURGERY. THEREFORE, THE APPLIER WAS REPLACED WITH ANOTHER ONE TO COMPLETE THE PROCEDURE. NO CLIP FELL/REMAINED IN THE PATIENT AND NO INJURY TO THE PATIENT OCCURRED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19773513 ↗
Other Applier, surgical, clip devices
- LIGACLIP MCS20Ethicon Endo-Surgery, LLC · Applier, surgical, clip1 death337 reports
- Endo Clip III 176630BCovidien LP · Applier, surgical, clip312 reports
- LIGACLIP MCM20Ethicon Endo-Surgery, LLC · Applier, surgical, clip308 reports
- LIGACLIP MCM30Ethicon Endo-Surgery, LLC · Applier, surgical, clip1 death236 reports
- WECK IPN915189Teleflex Incorporated · Applier, surgical, clip221 reports
- LIGACLIP MSM20Ethicon Endo-Surgery, LLC · Applier, surgical, clip152 reports
- LIGACLIP LX107Ethicon Endo-Surgery, LLC · Applier, surgical, clip105 reports
- LIGACLIP MCL20Ethicon Endo-Surgery, LLC · Applier, surgical, clip1 death57 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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