WECK IPN002005Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 14026704410245), received between Feb 23, 2023 and Jun 5, 2025 — classified as 1 death, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K982313); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT "DURING THE INSPECTION, IT WAS FOUND THAT 1 CARTRIDGE WAS UNSEALED, WITH NO SIGNS OF ADHESIVE OR ANY INDICATION THAT IT HAD BEEN SEALED". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152953 ↗
• MalfunctionSep 25, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT " THE SURGEON FOUND THAT COULD NOT BE DRIVEN IN". TO CONTINUE THE PROCEDURE, THE MEDICAL PROFESSIONAL CHANGED TO A NEW SET. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20303828 ↗
• MalfunctionSep 25, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT " THE SURGEON FOUND THAT COULD NOT BE DRIVEN IN". TO CONTINUE THE PROCEDURE, THE MEDICAL PROFESSIONAL CHANGED TO A NEW SET. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20303700 ↗
• MalfunctionJul 16, 2024Illegible Information; Illegible Information

  IT WAS REPORTED THAT "THERE SEEMS TO BE AN ISSUE WITH THE PRINTING OF LOT NUMBERS ON YOUR WECK CLIPS. THE INK ON THE PACKAGING APPEARS TO BE RUNNING WHICH SOMETIMES MAKES IT DIFFICULT TO READ/DOCUMENT THE LOT NUMBERS IN THE PATIENTS RECORD". NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 19751169 ↗
• InjuryMay 23, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED " A FEW HOURS INTO THE POST-OPERATIVE [PERIOD] THE PATIENT HAS ACTIVE BLEEDING FOR SUCH REASON, RE-INTERVENTION MUST BE INTERVENED AND IT CAN BE EVIDENCED THAT ALL LIGACLIP 'LT 100 LT 200' ARE LOOSE AND ARE NOT FULFILLING THEIR FUNCTION". THE PATIENT WAS TAKEN BACK TO SURGERY AGAIN TO STOP THE BLEEDING. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19386414 ↗
• DeathFeb 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORTED ISSUE: MULTIPLE CARDIAC POST-OP BLEEDS AS A RESULT OF LIGATING CLIPS COMING OFF ARTERIAL BRANCHES. THE PATIENT'S CONDITION IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16428635 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K982313. One submission often covers many models, so check the product and lot details in each record.

• Z-2327-2016 · Aug 8, 2013 · Terminated
  Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic stru