WECK IPN028384Recalls & reported problems
Teleflex Incorporated · HEM-O-LOK MEDIUM LARGE, ENDOSCOPIC APPLIER 5 MILIMETER, 45 CENTIMETER · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 34026704622499), received between Jan 3, 2024 and Jan 14, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Align2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2025Failure to Align; Failure to Align
IT WAS REPORTED THAT "THE POLYMER CLIPS ARE NOT LOADING IN THE JAW PROPERLY. THE ALIGNMENT OF THE JAW OF APPLIERS BECAME DEFECTIVE". NO REPORT OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21151480 ↗MalfunctionJan 10, 2024Break; Break
IT WAS REPORTED THAT "WHILE FINISHING A PROCEDURE THE ROD THAT ATTACHES THE TIP OF THE CLIP APPLIER BROKE OFF WITH NO PRIOR DAMAGE BEING PRESENT". ADDITIONAL INFORMATION RECEIVED STATES THAT "THE ROD THAT ATTACHES THE TOP OF THE CLIP APPLIER BROKE OFF". THE PATIENT STATUS IS REPORTED AS "UNHARMED, THERE WERE NO FRAGMENTS IN THE PATIENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18485201 ↗MalfunctionJan 3, 2024Failure to Align; Failure to Align
THE REPORT STATES THAT PRIOR TO USE IN THE CLINICAL SETTING, "BRAND NEW APPLIER- FIRST TIME USE, WOULD NOT HOLD CLIP SINCE JAW IS MISALIGNED AND PIN SEEMS TO BE THE PROBLEM". NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18436307 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.