WECK IPN923663Recalls & reported problems
Teleflex Incorporated · WECK EFx Shield Port Site Closure System · Class 1
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 14026704739001), received between Mar 30, 2022 and Jul 25, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Most reported problems
Device problems
- Break4
- Activation Problem1
- Defective Component1
- Material Disintegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 25, 2023Material Disintegration; Material Disintegration
THE REPORT STATES "METAL FLAKING". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.
Patient problems: Insufficient Information
MAUDE report 17389283 ↗MalfunctionMar 6, 2023Defective Component; Defective Component
REPORTED ISSUE: DURING A GASTRIC SLEEVE THE DEVICE TAB SNAPPED OFF. IT WAS RETRIEVED FROM PATIENT AND A NEW DEVICE WAS USED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16491631 ↗MalfunctionJan 4, 2023Break; Activation Problem; Break; Activation Problem
REPORTED ISSUE: DURING A GASTRIC SLEEVE PROCEDURE THE PRODUCT BROKE AND WAS UNABLE TO GRAB SUTURE. WHILE THE PRODUCT WAS BEING USED TO CLOSE THE FASCIA, A PIECE BROKE OFF INSIDE THE PATIENT; THE PIECE WAS REMOVED AND A NEW WECK WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16095724 ↗MalfunctionOct 6, 2022Break; Break
THE PRODUCT WAS USED DURING A GASTRIC SLEEVE PROCEDURE ON THE PATIENT WHEN A SMALL PORTION OF THE SUTURE HOLDER, THE ARROW/TAB BROKE OFF. THE DOCTOR REMOVED THE SHIELD AND RETRIEVED THE BROKEN PORTION. A SECOND PRODUCT WAS USED TO SUCCESSFULLY CLOSE THE FASCIA. NO PATIENT INJURY OR ADVERSE EFFECT. ADDITIONAL INFORMATION IDENTIFIED A PART OF THE SUTURE WING AS THE PART THAT BROKE. IT WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15550382 ↗MalfunctionMar 30, 2022Break; Break
THE FASCIAL CLOSURE SYSTEM IS BROKEN DURING USE IN BARIATRIC SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13957156 ↗MalfunctionMar 30, 2022Break; Break
USER INSERTED SHIELD WHILE DEPLOYING WINGS EARLY, ABDOMEN CAUSED PLASTIC ON SHIELD WING TO BREAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13957106 ↗
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 MB362RAesculap, Inc. · INSTRUMENT, LIGATURE PASSING AND KNOT TYING1 recall0 reports
- AESCULAP MB215RAesculap, 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.