WECK IPN028278Recalls & reported problems
Teleflex Incorporated · HEM-O-LOK APPLIER EXTRA LARGE 11" RIGHT ANGLED · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 34026704623601), received between Oct 26, 2023 and Jul 11, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Align” (1 report).
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 Align1
- Loose or Intermittent Connection1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT " JAWS NOT HOLDING THE CLIPS PROPERLY, CLIPS FALL OUT". NO PATIENT INVOLVEMENT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19721108 ↗MalfunctionOct 26, 2023Failure to Align; Failure to Align
IT WAS REPORTED THAT PRIOR TO USE, IT WAS FOUND THE APPLIER JAWS ARE MISALIGNED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18012226 ↗
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- WECK IPN028280Teleflex Incorporated · Applier, surgical, clip93 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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