WECK IPN914926Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 34026704696315), received between Aug 26, 2021 and Oct 26, 2022 — classified as 1 death, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathOct 26, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED "[ONE] FULLY DISLOCATED CLIP LEADING TO RETHORACOTOMY, AFTER HARVESTING THE VEIN GRAFT 1/3 OF THE CLIPS NOT FULLY OCCLUSIVE." ADDITIONAL INFORMATION RECEIVED STATED "THERE WERE 3 BYPASSES MADE WITH A VEIN FROM THE LEG. THERE WERE AROUND 10 CLIPS ON THE SIDE BRANCHES OF THOSE VEINS. ONE WAS TOTALLY OFF AND THE TWO OR THREE WERE STILL ON THE SIDE BRANCHES BUT SEEMED TO BE NOT FULLY CLOSED; STILL DRY BUT NOT TOTALLY CLOSED". IT WAS DESCRIBED THAT AFTER TWO HOURS AFTER WOUND CLOSURE, A REPEAT THORACOTOMY WAS PROMPTED DUE TO "BIG BLEEDING, DRAIN FULL OF BLOOD, AND VERY LOW BLOOD PRESSURE." PATIENT CONDITION WAS REPORTED AS EXPIRED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 15672526 ↗
• MalfunctionFeb 23, 2022Difficult to Open or Close; Difficult to Open or Close

  SURGEON WAS TRYING TO CLIP ABDOMINAL VESSELS IN PATIENT, CLIPS WERE APPLIED BUT NOTED TO BE SLIPPING ON THE VESSELS; NOT HOLDING AND SLIDING UP AND DOWN. APPLIERS CHECKED AND MET TELEFLEX APPLIER CARE STANDARD. CLIPS REMOVED FROM STERILE FIELD AND TESTED - THERE APPEARS TO BE SMALL GAP AT THE BOTTOM OF THE CLIP WHEN IT IS CLOSED AND THIS IS CAUSING THE CLIP TO SLIDE. SEVERAL CLIPS WERE TESTED AND OBSERVED TO BE DOING THE SAME THING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584298 ↗
• MalfunctionAug 26, 2021Unintended Movement; Unintended Movement

  MULTIPLE INCIDENCE OF ONE DOCTORS PATIENTS RETURNING AFTER CV PROCEDURES. HORIZON CLIPS HAVE SLIPPED OFF POST-OP. FOLLOW-UP REPORT INDICATES THAT 4 PATIENTS WERE AFFECTED OVER THE PAST YEAR WITH HORIZON CLIP OCCLUSION ISSUES. ALL PATIENTS WERE SUBSEQUENTLY LIGATED WITH AUTOMATIC METAL CLIP APPLIER. ONE PATIENT HAD TO RECEIVE SURGICAL INTERVENTION UPON READMITTANCE. THE FIRST INCIDENT DATE IS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12371504 ↗
• MalfunctionAug 26, 2021Unintended Movement; Unintended Movement

  MULTIPLE INCIDENCE OF ONE DOCTORS PATIENTS RETURNING AFTER CV PROCEDURES. HORIZON CLIPS HAVE SLIPPED OFF POST-OP. FOLLOW-UP REPORT INDICATES THAT 4 PATIENTS WERE AFFECTED OVER THE PAST YEAR WITH HORIZON CLIP OCCLUSION ISSUES. ALL PATIENTS WERE SUBSEQUENTLY LIGATED WITH AUTOMATIC METAL CLIP APPLIER. ONE (1) PATIENT HAD TO RECEIVE SURGICAL INTERVENTION UPON READMITTANCE. THE FIRST INCIDENT DATE IS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12371383 ↗
• InjuryAug 26, 2021Unintended Movement; Unintended Movement

  MULTIPLE INCIDENCE OF ONE DOCTORS PATIENTS RETURNING AFTER CV PROCEDURES. HORIZON CLIPS HAVE SLIPPED OFF POST-OP. FOLLOW-UP REPORT INDICATES THAT 4 PATIENTS WERE AFFECTED OVER THE PAST YEAR WITH HORIZON CLIP OCCLUSION ISSUES. ALL PATIENTS WERE SUBSEQUENTLY LIGATED WITH AUTOMATIC METAL CLIP APPLIER. ONE (1) PATIENT HAD TO RECEIVE SURGICAL INTERVENTION UPON READMITTANCE. THE FIRST INCIDENT DATE IS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12371228 ↗
• MalfunctionAug 26, 2021Unintended Movement; Unintended Movement

  MULTIPLE INCIDENCE OF ONE DOCTORS PATIENTS RETURNING AFTER CV PROCEDURES. HORIZON CLIPS HAVE SLIPPED OFF POST-OP. FOLLOW-UP REPORT INDICATES THAT 4 PATIENTS WERE AFFECTED OVER THE PAST YEAR WITH HORIZON CLIP OCCLUSION ISSUES. ALL PATIENTS WERE SUBSEQUENTLY LIGATED WITH AUTOMATIC METAL CLIP APPLIER. ONE (1) PATIENT HAD TO RECEIVE SURGICAL INTERVENTION UPON READMITTANCE. THE FIRST INCIDENT DATE IS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12371101 ↗

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