WECK IPN914925Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 24026704696363), received between Nov 2, 2021 and Jul 13, 2023 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2023Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CORONARY BYPASS SURGERY WHERE THE COLLATERAL OF THE ANASTOMOSED LONG SAPHENOUS VEIN GRAFT BETWEEN THE AORTA AND THE DIAGONAL CORONARY ARTERY WAS CLIPPED. ONE HOUR POSTOPERATIVELY, THE PATIENT EXPERIENCED CARDIAC ARREST SECONDARY TO HEMORRHAGIC SHOCK. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM WHERE IT WAS DISCOVERED THAT SOME OF THE CLIPS HAD MIGRATED AS WELL AS TO RE-OPEN THE PATIENT TO PERFORM HEMOSTASIS. THE ESTIMATED BLOOD WAS 3 LITERS. THE PATIENT DID NOT DIE.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17321535 ↗
• InjuryMay 23, 2023Failure to Form Staple; Lack of Effect; Failure to Form Staple; Lack of Effect

  THE REPORT STATES "TOTAL THYROIDECTOMY COMPLETED ON PATIENT. PATIENT TRANSFERRED OVER TO STRETCHER. DRAIN NOTED TO BE FULL, AND PATIENT'S NECK NOTED TO BE SWELLING. PATIENT TRANSFERRED BACK ONTO OR BED AND SURGICAL INCISION REOPENED. SURGEON NOTED THAT TITANIUM CLIP HAD COME OFF OF VESSEL AND WAS BLEEDING. UPON FURTHER EXAMINATION SURGEON NOTED THAT SEVERAL (7) OF THE CLIPS HAD COME OFF". AS A RESULT, A PROCEDURE TO PROPERLY CLOSE THE SURGICAL INCISION WAS PERFORMED. THE PATIENT STATUS IS REPORTED AS "STABLE". ASSOCIATED TO MDR 3003898360-2023-00820 FOR A DIFFERENT LOT NUMBER USED.

  Patient problems: Exsanguination

  MAUDE report 16988955 ↗
• InjuryMay 23, 2023Failure to Form Staple; Lack of Effect; Failure to Form Staple; Lack of Effect

  IT WAS REPORTED "TOTAL THYROIDECTOMY COMPLETED ON PATIENT. PATIENT TRANSFERRED OVER TO STRETCHER. DRAIN NOTED TO BE FULL, AND PATIENT'S NECK NOTED TO BE SWELLING. PATIENT TRANSFERRED BACK ONTO OR BED AND SURGICAL INCISION REOPENED. SURGEON NOTED THAT TITANIUM CLIP HAD COME OFF OF VESSEL AND WAS BLEEDING. UPON FURTHER EXAMINATION SURGEON NOTED THAT SEVERAL (7) OF THE CLIPS HAD COME OFF". AS A RESULT, A PROCEDURE TO PROPERLY CLOSE THE SURGICAL INCISION WAS PERFORMED. THE PATIENT STATUS IS REPORTED AS "STABLE". ADDITIONAL INFORMATION REQUESTED REGARDING TOTAL CARTRIDGES USED. AT TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED BY COMPLAINANT.

  Patient problems: Exsanguination

  MAUDE report 16988791 ↗
• InjuryOct 26, 2022Device Fell; Device Fell

  IT WAS REPORTED THAT THE PATIENT HAD AN OPEN-HEART SURGERY. THE SURGEON WAS APPLYING A BLUE HORIZON CLIP TO A TARGET BUT IT ACCIDENTALLY FELL DOWN INTO THE CHEST CAVITY BEFORE PLACEMENT. THE SURGEON ATTEMPTED TO PICK UP THE CLIP IMMEDIATELY USING INSTRUMENTS AND SUCTION BUT WAS UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 15674084 ↗
• InjuryAug 17, 2022Positioning Failure; Positioning Failure

  INCIDENT OCCURRED ON (B)(6) 2022, INVOLVED AN 80-YEAR-OLD PATIENT TREATED FOR BYPASS SURGERY CORONARY LEFT INTERNAL MAMMARY ON POSTEROLATERAL AND RIGHT INTERNAL MAMMARY ON ANTERIOR INTERVENTRICULAR UNDER CIRCULATION EXTRA BODILY. DURING THE INTERVENTION THE CLIPS SELF-REMOVED FROM THE INTERNAL BREAST ON WHICH THEY HAD BEEN APPLIED. CONSEQUENCE: SIGNIFICANT BLOOD LOSS OF 400 ML. PROXIMAL TEAR BLEEDING OF THE RIGHT INTERNAL MAMMARY ARTERY REQUIRED A VASCULAR FILLING , NOREPINEPHRINE AND THEN CONTINUOUS FOLLOW UP. DURING POSTOPERATIVE FOLLOW UP, WE OBSERVED A POSTOPERATIVE BLEEDING THAT STOPPED AFTER GIVING 2G OF FIBRINOGEN TO THE PATIENT. PATIENT IS FINE, HE WAS DISCHARGED ON (B)(6) 2022 AND LEFT THE HOSPITAL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 15243121 ↗
• InjuryJun 7, 2022Positioning Failure; Positioning Failure

  CLIPS WERE SPRINGING OFF VESSELS AND FAILING TO CLAMP. CLIPS WERE TESTED OFF THE PATIENT AND APPEARED TO WORK NORMALLY. ISSUE ONLY OCCURRED WHEN LIGATING VESSEL USING MULTIPLE DIFFERENT APPLIERS. ISSUE OCCURRED WITH MULTIPLE SURGEONS AND SCRUB NURSES, AND ONLY WHEN THE LOT NUMBER CHANGED DID THE CLIPS WORK NORMALLY. CLIPS WERE INSPECTED NEXT DAY BY TFX TERRITORY MANAGER AND TESTED WITH 1 OF THEIR APPLIERS, SUSPECT THAT APPLIERS MAY NEED TO BE REPLACED AS CLIPS WERE PARTIALLY COMPRESSED AFTER LOADING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14618531 ↗
• InjuryJun 7, 2022Positioning Failure; Positioning Failure

  CLIPS WERE SPRINGING OFF VESSELS AND FAILING TO CLAMP. CLIPS WERE TESTED OFF THE PATIENT AND APPEARED TO WORK NORMALLY. ISSUE ONLY OCCURRED WHEN LIGATING VESSEL USING MULTIPLE DIFFERENT APPLIERS. ISSUE OCCURRED WITH MULTIPLE SURGEONS AND SCRUB NURSES, AND ONLY WHEN THE LOT NUMBER CHANGED DID THE CLIPS WORK NORMALLY. CLIPS WERE INSPECTED NEXT DAY BY TFX TERRITORY MANAGER AND TESTED WITH 1 OF THEIR APPLIERS, SUSPECT THAT APPLIERS MAY NEED TO BE REPLACED AS CLIPS WERE PARTIALLY COMPRESSED AFTER LOADING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14618392 ↗
• MalfunctionMar 26, 2022Positioning Failure; Positioning Failure

  RECEIVED CALL FROM SENIOR STAFF NURSE TO BE ADVISED THAT DURING A CORONARY ARTERY BYPASS GRAFT THEY HAD A NUMBER OF CLIP FAILURES (10+). THE NURSE WAS NOT IN THE CASE SO SHE IS UNAWARE OF HOW IT WAS RESOLVED. SHE BELIEVES THAT THE PATIENT'S CONDITION IS OKAY. THE NURSE IS GOING TO CONFIRM THE LOT NUMBER OF THE CLIPS USED AND IS REQUESTING FOR THE APPLIERS TO BE DECONTAMINATED AND QUARANTINED. I HAVE ARRANGED TO GO IN WEDNESDAY TO INSPECT THE APPLIERS AND GATHER FURTHER DETAILS FROM SURGICAL TEAM. I AM ADVISED PHOTOS WERE TAKEN AND THE CLINICAL LEAD WAS CALLED IN TO OBSERVE THE ISSUE. THE APPLIERS WERE NEW APPLIERS. THEY HAVE BEEN USED ONLY DURING THE PAST 3 WEEK. I WILL BE ABLE TO IDENTIFY HOW MANY TIMES THEY HAVE BEEN PROCESSED AFTER WEDNESDAY. CLINICAL CONSEQUENCES: MEDICAL INTERVENTION WAS NECESSARY DUE TO THE ALLEGED ISSUE. ADDITIONAL INFORMATION: IT IS PROBABLE THAT SUTURES WERE NEEDED TO LIGATE THE VESSEL PROPERLY BUT SHE IS WAITING FOR CONFIRMATION FROM THE SURGEON. SHE COLLECTED 5 CARTRIDGES OF REPRESENTATIVE CLIPS AND THE APPLIERS. ALL FOUR OF THE MEDIUM APPLIERS WOULD HAVE BEEN USED DURING THE PROCEDURE BUT SHE COULD NOT SAY WHICH ONE IF ANY WAS RESPONSIBLE FOR THE PROBLE

  Patient problems: Insufficient Information

  MAUDE report 13916007 ↗
• MalfunctionNov 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PROCEDURE WAS A CABG. HE HAD A CASE WHERE A COUPLE OF CLIPS CAME OFF THE SAPHENOUS VEIN WHEN PRESSURE DELIVERED TO THE HARVESTED VEIN. HE SAID THIS CAN HAPPEN AND HE WAS NOT OVERLY CONCERNED AT THIS STAGE AS IT ONLY HAPPENED THE ONCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737694 ↗
• InjuryNov 2, 2021Mechanical Problem; Detachment of Device or Device Component; Migration; Mechanical Problem; Detachment of Device or Device Component; Migration

  A CLIP CAME OFF DURING A PROCEDURE LEADING THE SURGEON TO SUTURE THE VESSEL. THE OTHER REPORTED INCIDENT IS THAT THE CLIP DID NOT OCCLUDE THE VESSEL BUT TIP AND HINGE WERE MEETING. THE CLINICAL LEAD DOES NOT HAVE THE SPECIFIC DETAILS OF THE INCIDENTS AND HAS GIVEN ME THE EMAIL OF A SURGEON WHO DEALS WITH GOVERNANCE TO REQUEST FROM HIM. AS SOON AS I HAVE FURTHER DETAILS I WILL PROVIDE. ADDITIONAL INFORMATION: THE PROCEDURE WAS A CABG. THE SAPHENOUS VEIN WAS PREPARED. IT WAS DESCRIBED AS THE CLIPS CUT THROUGH THE VESSEL WHEN APPLIED SO VEIN WAS LEAKING IN 3 TO 4 AREAS. WHEN THEY TOOK THE PATIENT OFF BYPASS THEY HAD A LOT OF BLOOD AROUND THE RIGHT HAND SIDE OF RHE HEART WHERE THE CLIP HAD CUT THROUGH THE BRANCH OF VEIN. SURGEON OVER SUTURE THE VESSELS TO ENSURE PROPER CLOSURE. NO ISSUES POST SURGERY REPORTED WITH PATIENT. HE FELT HE HAD A SIMILAR INCIDENT AROUND A MONTH AGO.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 12737639 ↗

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