WECK IPN914939Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 24026704709957), received between Jul 20, 2021 and Aug 23, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionAug 23, 2022Mechanics Altered; Mechanics Altered

  WE GOT THE FEEDBACK FROM HORIZON APPLIER ITEM NUMBER 137082, WHAT CUSTOMER HAS USED DECADES. HELSINKI UNIVERSITY HOSPITAL IS THE CLIENT. THEY ARE USING ALWAYS WITH HORIZON CLIPS WITH HORIZON APPLIER. THEY HAVE USED ALSO ALWAYS YOUR MAINTENANCE SERVICE, WHEN THEY GOT NEW REPAIRED APPLIERS, WHEN THEY SEND BACK TO REPAIR USED APPLIERS TO YOU. PAST 6 MONTHS SURGEONS HAVE NOTICED THAT CLIPS ARE NOT HOLD TIGHT AND DROP TO SURGICAL SITE FROM APPLIER AND IT ALWAYS APPLIER REPAIRED 137082, OTHER SIZE OF APPLIERS WORKING PERFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277976 ↗
• MalfunctionJul 11, 2022Nonstandard Device; Nonstandard Device

  PAST 6 MONTHS SURGEONS HAVE NOTICED, THAT CLIPS ARE NOT HOLDING TIGHT AND DROP TO SURGICAL SITE FROM APPLIER AND IT ALWAYS APPLIER REPAIRED 137082, OTHER SIZE OF APPLIERS WORKING PERFECT. NO INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14982627 ↗
• 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 12196663 ↗
• 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 12196604 ↗
• 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 12196515 ↗
• 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 12196496 ↗
• 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 TOO 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 12196480 ↗
• 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 12196459 ↗
• 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. 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 12196422 ↗
• 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 12196385 ↗