WECK IPN917216Recalls & reported problems
Teleflex Incorporated · WECK EFx Shield Port Site Closure System · Class 1
All models of WECK (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 14026704736321), received between Oct 8, 2024 and Oct 8, 2024 — classified as 1 malfunction.
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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2024
WHEN THE DEVICE WAS DEPLOYED, THE TEAM HEARD A SNAP. THEY EXAMINED THE DEVICE AND THE SIDE PART HAS BROKEN OFF. ANOTHER SIMILAR DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT. MANUFACTURER RESPONSE FOR INSTRUMENT, LIGATURE PASSING AND KNOT TYING, WECK (PER SITE REPORTER). ROBOTIC COORDINATOR SPOKE TO FIELD REPRESENTATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20395912 ↗
Other INSTRUMENT, LIGATURE PASSING AND KNOT TYING devices
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- IDEAL 251003Medos International Sàrl · INSTRUMENT, LIGATURE PASSING AND KNOT TYING87 reports
- OverStitch Endoscopic Suturing System ESS-G02-160Apollo Endosurgery, Inc. · Instrument, Ligature Passing And Knot Tying4 deaths76 reports
- M-Close Kit 27-101New Wave Endo-Surgery Inc. · Instrument, Ligature Passing And Knot Tying1 recall3 reports
- AESCULAP MB215RAesculap, Inc. · INSTRUMENT, LIGATURE PASSING AND KNOT TYING1 recall0 reports
- AESCULAP MB362RAesculap, Inc. · INSTRUMENT, LIGATURE PASSING AND KNOT TYING1 recall0 reports
- OverStitch Endoscopic Suturing System CNH-G01-000Apollo Endosurgery, Inc. · Instrument, Ligature Passing And Knot Tying48 reports
- IDEAL 251004Medos International Sàrl · INSTRUMENT, LIGATURE PASSING AND KNOT TYING42 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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