WECK IPN914218Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 14026704645272), received between Apr 21, 2021 and Dec 22, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT "SHIELD CLOSURE DEVICE PREPPED AS NORMAL AND USED FOR FASCIAL CLOSURE OF A PATIENT. WHILE INTO ABDOMEN, IT BROKE, BUT NOT APART. SHIELD WAS INTACT AND REMOVED CAREFULLY. NO HARM TO PATIENT". ADDITIONAL INFORMATION RECEIVED STATES THAT "THE SHIELD BROKE INSIDE THE ABDOMEN, BUT NOT APART-THIS OCCURRED DURING THE WING FIXTURE PHASE. THE SHIELD WAS PROPERLY REMOVED WITHOUT ANY PARTS FALLING OFF IT". ANOTHER SHIELD DEVICE WAS OPENED AND USED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871405 ↗
• MalfunctionAug 22, 2023Break; Break

  IT WAS REPORTED THAT THE "SHIELD BROKE ON A FEMALE PATIENT. THE SHIELD WING CAME APART. [THE DOCTOR] ASSURES THE PATIENT WAS OK AND THERE WERE NO COMPLICATIONS. HE SAID EVERYTHING WAS FINE. HE JUST WANTED TO KNOW WHAT HE DID TO BREAK THE PRODUCT". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596998 ↗
• MalfunctionNov 2, 2021Break; Break

  BROKE WHEN INSERTING INTO THE FASCIA. NO PATIENT INJURY. ADDITIONAL INFORMATION: THE SHIELD PART SNAPPED WHEN HE INSERTED INTO THE FASCIA. PROBABLY TOO HARD AND GOT CAUGHT. NOTHING FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12736588 ↗
• MalfunctionJun 30, 2021Break; Break

  A PORTION OF ONE SIDE OF THE WING OF THE EFX SHIELD BROKE OFF WHILE PULLING THE PRODUCT OUT OF THE DEFECT. THE PATIENT WAS NOT INJURED TO MY KNOWLEDGE, NOR HARMED IN ANY WAY. NOT SURE WHY THIS HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091467 ↗
• MalfunctionJun 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PLASTIC "V" AT THE BOTTOM PF THE DEVICE BECAME DETACHED WHILE INSIDE OF PATIENT. ADDITIONAL INFORMATION: YES, IT DID FALL INSIDE THE PATIENT BUT WAS RETRIEVED AT THE TIME WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12049557 ↗
• MalfunctionJun 17, 2021Break; Break

  SIDE OF WING BROKE WHILE IN PATIENT. NO PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12017677 ↗
• MalfunctionMay 13, 2021Material Twisted/Bent; Material Twisted/Bent

  I WANTED TO BRING IT TO THE ATTENTION OF THE APPROPRIATE TEAM AN ISSUE WE EXPERIENCED LAST NIGHT DURING A TRIAL WITH PRODUCT NUMBER EFX002 AND ACCOUNT 137700. I PROPERLY IN-SERVICED THE ACCOUNT, THE SURGEON, SCRUB TECH AND FIRST ASSIST IN LOADING AND USING THE EFX002 WECK SHIELD FASCIAL CLOSURE DEVICE. UPON ENTERING THE DEVICE INTO THE PATIENT DEFECT, THE SUTURE RETRIEVER WENT DOWN THE FIRST HOLE ON THE SIDE TO RETRIEVE THE SUTURE WHICH WAS DONE SUCCESSFULLY. WHEN THE USER WENT DOWN THE SECOND HOLE TO RETRIEVE THE SECOND PART OF THE SUTURE, THEY WERE EXPERIENCING ISSUES WITH RETRIEVING THE SUTURE. THE SUTURE RETRIEVER BENT WHERE THE METAL SHARP MEETS THE PLASTIC. I HAVE ATTACHED PICTURES AND VIDEOS. I DO NOT HAVE THE PRODUCT CODE TO IDENTIFY THE ACTUAL BATCH OR ANY SPECIFIC INFORMATION BUT I WANTED TO BRING TO THE THE ATTENTION OF OUR CLAIMS TEAM THAT THE DEVICE WAS FAULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819455 ↗
• MalfunctionApr 22, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  PART OF PLASTIC SPLIT DETACHED FROM SIDE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11706721 ↗
• MalfunctionApr 21, 2021Break; Break

  DURING SECOND DEPLOYMENT ONE OF THE WINGS BROKE INSIDE THE PATIENT. OCCURRENCE DID NOT CHANGE OUTCOME. THERE WAS NO PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700797 ↗