WECK IPN914955Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 24026704710038), received between Jul 20, 2021 and Feb 28, 2023 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORTED ISSUE: 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 16452976 ↗
• MalfunctionMar 26, 2022Difficult to Open or Close; Difficult to Open or Close

  RECEIVED CALL FROM SENIOR STAFF NURSE TO BE ADVISED THAT DURING A CORONARY ARTERY BYPASS GRAFT THEY HAD A NUMBER OF CLIPS FAILURES (10+), SHE WAS NOT IN CASE SO IS UNAWARE OF HOW IT WAS RESOLVED. SHE BELIEVES PATIENT CONDITION IS OKAY. THIS IS AN ACCOUNT THAT IS TRIALING THE HORIZON CLIPS AS A HEMOCLIP REPLACEMENT FOR WHEN IT IS DISCONTINUED THIS YEAR. ISSUE: CLIP FAILURE DURING USE ON BOTH THE MAMMARY (PROF) AND VEIN HARVEST (ADNAN). 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 ON WEDNESDAY TO INSPECT THE APPLIERS AND GATHER FURTHER DETAILS FROM SURGICAL TEAM. I AM ADVISED PHOTOS WERE TAKEN AND CLINICAL LEAD GO WAS CALLED IN TO OBSERVE THE ISSUE. THE APPLIERS WERE NEW APPLIERS, THEY HAVE BEEN USED ONLY DURING THE PAST 3 WEEKS. I WILL BE ABLE TO IDENTIFY HOW MANY TIMES THEY HAVE BEEN PROCESSED AFTER WEDNESDAY. THE CUSTOMER USED ALL FOUR APPLIERS DURING THE CASE, IF AN APPLIER WAS AT FAULT, WHICH CAUSED THE CLIPS TO NOT CLOSE PROPERLY THEN IT COULD BE ANY ONE OF THE FOUR APPLIERS FROM THE SET. I HAVE CHECKED THE APPLIERS MYSELF AND CANNOT SEE AN OBVIOUS DEFECT. I AM NO

  Patient problems: Insufficient Information

  MAUDE report 13916443 ↗
• MalfunctionMar 26, 2022Difficult to Open or Close; Difficult to Open or Close

  RECEIVED CALL FROM SENIOR STAFF NURSE TO BE ADVISED THAT DURING A CORONARY ARTERY BYPASS GRAFT THEY HAD A NUMBER OF CLIPS FAILURES (10+), SHE WAS NOT IN CASE SO IS UNAWARE OF HOW IT WAS RESOLVED. SHE BELIEVES PATIENT CONDITION IS OKAY. THIS IS AN ACCOUNT THAT IS TRIALING THE HORIZON CLIPS AS A HEMOCLIP REPLACEMENT FOR WHEN IT IS DISCONTINUED THIS YEAR. ISSUE: CLIP FAILURE DURING USE ON BOTH THE MAMMARY (PROF) AND VEIN HARVEST (ADNAN). 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 ON WEDNESDAY TO INSPECT THE APPLIERS AND GATHER FURTHER DETAILS FROM SURGICAL TEAM. I AM ADVISED PHOTOS WERE TAKEN AND CLINICAL LEAD GO WAS CALLED IN TO OBSERVE THE ISSUE. THE APPLIERS WERE NEW APPLIERS, THEY HAVE BEEN USED ONLY DURING THE PAST 3 WEEKS. I WILL BE ABLE TO IDENTIFY HOW MANY TIMES THEY HAVE BEEN PROCESSED AFTER WEDNESDAY. THE CUSTOMER USED ALL FOUR APPLIERS DURING THE CASE, IF AN APPLIER WAS AT FAULT, WHICH CAUSED THE CLIPS TO NOT CLOSE PROPERLY THEN IT COULD BE ANY ONE OF THE FOUR APPLIERS FROM THE SET. I HAVE CHECKED THE APPLIERS MYSELF AND CANNOT SEE AN OBVIOUS DEFECT. I AM NO

  Patient problems: Insufficient Information

  MAUDE report 13916131 ↗
• MalfunctionMar 26, 2022Difficult or Delayed Activation; Difficult or Delayed Activation

  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 13915905 ↗
• MalfunctionMar 26, 2022Difficult to Open or Close; Difficult to Open or Close

  RECEIVED CALL FROM SENIOR STAFF NURSE TO BE ADVISED THAT DURING A CORONARY ARTERY BYPASS GRAFT THEY HAD A NUMBER OF CLIPS FAILURES (10+), SHE WAS NOT IN CASE SO IS UNAWARE OF HOW IT WAS RESOLVED. SHE BELIEVES PATIENT CONDITION IS OKAY. THIS IS AN ACCOUNT THAT IS TRIALING THE HORIZON CLIPS AS A HEMOCLIP REPLACEMENT FOR WHEN IT IS DISCONTINUED THIS YEAR. ISSUE: CLIP FAILURE DURING USE ON BOTH THE MAMMARY (PROF) AND VEIN HARVEST (ADNAN). 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 ON WEDNESDAY TO INSPECT THE APPLIERS AND GATHER FURTHER DETAILS FROM SURGICAL TEAM. I AM ADVISED PHOTOS WERE TAKEN AND CLINICAL LEAD GO WAS CALLED IN TO OBSERVE THE ISSUE. THE APPLIERS WERE NEW APPLIERS, THEY HAVE BEEN USED ONLY DURING THE PAST 3 WEEKS. I WILL BE ABLE TO IDENTIFY HOW MANY TIMES THEY HAVE BEEN PROCESSED AFTER WEDNESDAY. THE CUSTOMER USED ALL FOUR APPLIERS DURING THE CASE, IF AN APPLIER WAS AT FAULT, WHICH CAUSED THE CLIPS TO NOT CLOSE PROPERLY THEN IT COULD BE ANY ONE OF THE FOUR APPLIERS FROM THE SET. I HAVE CHECKED THE APPLIERS MYSELF AND CANNOT SEE AN OBVIOUS DEFECT. I AM NO

  Patient problems: Insufficient Information

  MAUDE report 13915155 ↗
• InjuryDec 6, 2021Failure to Align; Failure to Align

  CABG PROCEDURE. USING THE NEW LIGACLIPS AND APPLICATORS. AT THE END OF THE PROCEDURE AND DURING A PERIOD OF HYPERTENSION (140MMHG SYSTOLIC) THREE OF THE LIGACLIPS ON VEIN BRANCHES BECAME DISLODGED AND THE BRANCHES REQUIRED SUTURING. AT THE BEGINNING OF THE CASE WHEN CHECKING THE VEIN, LIKEWISE, 2 OF THE CLIPS HAD CUT THROUGH REQUIRING REVISION WITH SUTURES. CHECKED WITH SCRUB NURSE AND DEFINITELY THE CORRECT APPLICATORS WERE BEING USED FOR THE NEW CLIPS THE OLDER CLIPS HAVE DIFFERENT APPLICATORS. VERY UNUSUAL IN MY EXPERIENCE TO SEE THIS ON MULTIPLE CLIPS RAISING THE POSSIBILITY OF DEVICE FAILURE. SPEAKING TO COLLEAGUES IT APPEARS THAT THEY HAVE ALSO HAD INCIDENTS OF CLIP FAILURE WITH THE NEW CLIPS BOTH MIGRATING AND CUTTING THROUGH. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 12934939 ↗
• InjuryNov 18, 2021Separation Problem; Separation Problem

  INCIDENT HAPPENED ON THE (B)(6) 2021 IN SURGERY ROOM. DURING A THYROID SURGERY, THE DOCTOR HAD TO USE A BLUE TITANIUM CLIP REF (B)(4); LOT 73J2000654. THE CLIP DID NOT HOLD ON THE THYROID ARTERY. THIS CLIP GOT STUCK ON ONE OF THE JAWS THE HORIZON MEDIUM CLIP PLIERS 237081 LOT 06K1757772. THAT INJURED THE ARTERY WHEN THE SURGEON REMOVED THE APPLIER CAUSING SIGNIFICANT BLEEDING. FACING THIS URGENCY SITUATION THE SURGEON USED A SMALLER HEMOSTASIS FORCEPS CAT # 137081 + CLIP 001200 LOT# 73J2000649 WHICH CAUSED A LOSS OF SIGNAL FROM THE RECURRENT NERVE WHICH CONTROLS VOICE FUNCTION. CONSEQUENCE: PER-OPERATIVE BLEEDING AND POSSIBLE RECURRENT NERVE DAMAGE. THIS PROBLEM HAS OCCURRED SEVERAL TIMES WITHOUT CONSEQUENCE FOR PATIENTS. EACH TIME WE CHANGED THE APPLIER AND FOR THIS INCIDENT THE APPLIER HAD BEEN CHANGED 15 DAYS BEFORE. SINCE THIS INCIDENT SALES REPRESENTATIVE WENT ON SITE ON MONDAY 08 NOVEMBER AND CHANGED APPLIERS. THE PATIENT'S CONDITION IS FINE. THE RECURRENT NERVE IS NON-FUNCTIONAL POSTOPERATIVELY. THERE WERE NO UNDERLYING MEDICAL CONDITIONS. THE REPORTED CLIPS AND APPLIER WERE CONFIRMED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Nerve Damage

  MAUDE report 12836630 ↗
• MalfunctionSep 27, 2021Separation Problem; Separation Problem

  WHILE CLIPPING A BLOOD VESSEL, AFTER CLOSING THE CLIP, THE CLIP GOT STUCK TO THE APPLIER. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12531971 ↗
• MalfunctionJul 20, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  JAWS ARE TWISTING AND NOT HOLDING THE CLIPS, WHEN TAKING DOWN IMA (INFERIOR MESENTERIC ARTERY) IN CARDIAC CASE, CORONARY ARTERY BYPASS (CAGS). DAMAGED TO THE IMA OCCURRED. LATEST INCIDENT OCCURRED ON FRIDAY (B)(6) 2021 BUT HAS BEEN REPORTED FOR THE LAST 6 MONTHS. REFURBISHED REPLACEMENT APPLIERS WERE SWAPPED OVER, HOWEVER ISSUE STILL OCCURRED. APPLIERS SENDING BACK ARE FROM PRIOR, WILL SEND REMAINING WHEN RECEIVED. CUSTOMER DESCRIBED DAMAGE AS SHREDDING OF THE IMA. NEW CLIP APPLIER WAS USED UNTIL SUITABLE, CLIPPED ABOVE PREVIOUSLY DAMAGED AREA. IMA WAS STILL ABLE TO BE HARVESTED FOR BYPASS. PATIENT IS FINE, SURGERY WAS STILL SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196677 ↗
• MalfunctionJul 20, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  JAWS ARE TWISTING AND NOT HOLDING THE CLIPS, WHEN TAKING DOWN IMA (INFERIOR MESENTERIC ARTERY) IN CARDIAC CASE, CORONARY ARTERY BYPASS (CAGS). DAMAGED TO THE IMA OCCURRED. LATEST INCIDENT OCCURRED ON FRIDAY (B)(6) 2021 BUT HAS BEEN REPORTED FOR THE LAST 6 MONTHS. REFURBISHED REPLACEMENT APPLIERS WERE SWAPPED OVER, HOWEVER ISSUE STILL OCCURRED. APPLIERS SENDING BACK ARE FROM PRIOR, WILL SEND REMAINING WHEN RECEIVED. CUSTOMER DESCRIBED DAMAGE AS SHREDDING OF THE IMA. NEW CLIP APPLIER WAS USED UNTIL SUITABLE, CLIPPED ABOVE PREVIOUSLY DAMAGED AREA. IMA WAS STILL ABLE TO BE HARVESTED FOR BYPASS. PATIENT IS FINE, SURGERY WAS STILL SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196626 ↗