WECK IPN028179Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 34026704622611), received between May 16, 2023 and Jan 8, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (13 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT "THE JAWS GOT MISALIGNED DURING USE. THEREFORE, THE APPLIER WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO CLIP FELL/REMAINED IN THE PATIENT, AND NO INJURY TO THE PATIENT OCCURRED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105094 ↗
• InjuryDec 19, 2024Migration; Migration

  IT WAS REPORTED THAT AFTER CARDIAC SURGERY IN THE IMMEDIATE POSTOPERATIVE PERIOD, "THE PATIENT PRESENTED A PICTURE OF CARDIAC TAMPON ADE ATTRIBUTED TO DISLODGEMENT OF A TITANIUM CLIP. THIS SITUATION REQUIRED EMERGENCY SURGERY AND BLEEDING WAS FOUND AT THE LEVEL OF ONE OF THE CORONARY BRIDGES". A NEW CLIP WAS USED ALONGSIDE REINFORCEMENT WITH SILK TO ENSURE HEMOSTASIS. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Exsanguination

  MAUDE report 20978963 ↗
• MalfunctionMay 20, 2024Failure to Align; Failure to Align

  IT WAS REPORTED "THE CLIP COULD NOT BE LOADED TO THE APPLIER FIRMLY DURING A TEST BEFORE USE. THEREFORE, ANOTHER APPLIER WAS USED INSTEAD". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354645 ↗
• MalfunctionJan 25, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THAT "THE CLIP COULD NOT BE LOADED TO THE APPLIER FIRMLY AND IT ALMOST FELL OFF DURING A SURGERY. (IT DID NOT ACTUALLY FALL OFF.) THEREFORE, THE APPLIER WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO CLIP FELL/REMAINED IN THE PATIENT, AND NO INJURY TO THE PATIENT OCCURRED. THE APPLIER WAS SENT TO OUR TECHNICAL SPECIALIST, WHO CONFIRMED THE JAWS WERE MISALIGNED. THE APPLIER WAS PURCHASED BY THE HOSPITAL ON (B)(6) 2023 AND IT WAS THE FIRST TIME TO USE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18583013 ↗
• MalfunctionJan 18, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THAT "THE JAWS WERE FOUND MISALIGNED WHEN THE APPLIER WAS CHECKED AFTER CLEANING AFTER USE". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536363 ↗
• MalfunctionJan 18, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THAT "THE JAWS WERE FOUND MISALIGNED WHEN THE APPLIER WAS CHECKED AFTER CLEANING AFTER USE". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536346 ↗
• MalfunctionJan 18, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THAT "THE JAWS WERE FOUND MISALIGNED WHEN THE APPLIER WAS CHECKED AFTER CLEANING AFTER USE". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536338 ↗
• MalfunctionJan 18, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THAT "THE JAWS WERE FOUND MISALIGNED WHEN THE APPLIER WAS CHECKED AFTER CLEANING AFTER USE". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536329 ↗
• MalfunctionDec 7, 2023Device Handling Problem; Device Handling Problem

  THE REPORT STATES PRIOR TO USE, "CUSTOMER IS HAVING ISSUES WITH THE TIP OF THE APPLIERS AND THE APPLIERS NOT GRABBING THE CLIP PROPERLY. IT LOOKS LIKE THE JAW IS SLIGHTLY WIDER IN THE NEW APPLIERS JUST RECEIVED". ADDITIONAL INFORMATION STATES "ONE WOULDN'T PICK UP THE CLIP AS THE MOUTH WAS TOO WIDE AND GRAB IT, AND THE SECOND ONE BENT THE CLIPS". NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 18282220 ↗
• MalfunctionDec 7, 2023Device Handling Problem; Device Handling Problem

  THE REPORT STATES PRIOR TO USE, "CUSTOMER IS HAVING ISSUES WITH THE TIP OF THE APPLIERS AND THE APPLIERS NOT GRABBING THE CLIP PROPERLY. IT LOOKS LIKE THE JAW IS SLIGHTLY WIDER IN THE NEW APPLIERS JUST RECEIVED". ADDITIONAL INFORMATION STATES "ONE WOULDN'T PICK UP THE CLIP AS THE MOUTH WAS TOO WIDE AND GRAB IT, AND THE SECOND ONE BENT THE CLIPS". NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 18282173 ↗
• MalfunctionJun 30, 2023Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE APPLIER JAWS WERE FOUND MISALIGNED WHEN IT WAS CHECKED BEFORE USE. ANOTHER DEVICE WAS USED IN THE PROCEDURE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237685 ↗
• MalfunctionMay 17, 2023Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A TRIPLE CORONARY ARTERY BYPASS GRAFT BETWEEN ANTERIOR INTERVENTRICULAR ARTERY, WHEN ATTEMPTING TO REMOVE THE LEFT INTERNAL MAMMARY ARTERY, THE JAWS OF THE APPLIER MISALIGNED AND "ALTERED THE ARTERY". THE MISALIGNMENT OCCURRED ON THE FIRST CLIP OF THE APPLIER. ADDITIONAL INFORMATION STATES, "THE SURGEON SIMPLY SPECIFIED THAT THE ARTERY WAS DAMAGED, WITHOUT FURTHER DETAILS. IN TOTAL FOR THIS INTERVENTION WE RECOVERED 5 PLIERS, 2 FROM LOT 06D1517606 (LOT ASSOCIATED WITH THE INJURED ARTERY), 1 FROM LOT 562472-029, 1 FROM LOT 316340 AND 1 FROM LOT 06C1400093. ACCORDING TO THE SURGEON, NONE OF THE FORCEPS GAVE SATISFACTION, WITH CROSSING JAWS." FURTHER INFORMATION STATES THAT "THERE WERE NO CONSEQUENCES FOR THE PATIENT AND [THE DOCTOR] CONTINUED THE TRIPLE CORONARY ARTERY BYPASS SURGERY". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947234 ↗
• MalfunctionMay 17, 2023Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A TRIPLE CORONARY ARTERY BYPASS GRAFT BETWEEN ANTERIOR INTERVENTRICULAR ARTERY, WHEN ATTEMPTING TO REMOVE THE LEFT INTERNAL MAMMARY ARTERY, THE JAWS OF THE APPLIER MISALIGNED AND "ALTERED THE ARTERY". THE MISALIGNMENT OCCURRED ON THE FIRST CLIP OF THE APPLIER. ADDITIONAL INFORMATION STATES, "THE SURGEON SIMPLY SPECIFIED THAT THE ARTERY WAS DAMAGED, WITHOUT FURTHER DETAILS. IN TOTAL FOR THIS INTERVENTION WE RECOVERED 5 PLIERS, 2 FROM LOT 06D1517606 (LOT ASSOCIATED WITH THE INJURED ARTERY), 1 FROM LOT 562472-029, 1 FROM LOT 316340 AND 1 FROM LOT 06C1400093. ACCORDING TO THE SURGEON, NONE OF THE FORCEPS GAVE SATISFACTION, WITH CROSSING JAWS." FURTHER INFORMATION STATES THAT "THERE WERE NO CONSEQUENCES FOR THE PATIENT AND [THE DOCTOR] CONTINUED THE TRIPLE CORONARY ARTERY BYPASS SURGERY". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947216 ↗
• MalfunctionMay 17, 2023Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A TRIPLE CORONARY ARTERY BYPASS GRAFT BETWEEN ANTERIOR INTERVENTRICULAR ARTERY, WHEN ATTEMPTING TO REMOVE THE LEFT INTERNAL MAMMARY ARTERY, THE JAWS OF THE APPLIER MISALIGNED AND "ALTERED THE ARTERY". THE MISALIGNMENT OCCURRED ON THE FIRST CLIP OF THE APPLIER. ADDITIONAL INFORMATION STATES, "THE SURGEON SIMPLY SPECIFIED THAT THE ARTERY WAS DAMAGED, WITHOUT FURTHER DETAILS. IN TOTAL FOR THIS INTERVENTION WE RECOVERED 5 PLIERS, 2 FROM LOT 06D1517606 (LOT ASSOCIATED WITH THE INJURED ARTERY), 1 FROM LOT 562472-029, 1 FROM LOT 316340 AND 1 FROM LOT 06C1400093. ACCORDING TO THE SURGEON, NONE OF THE FORCEPS GAVE SATISFACTION, WITH CROSSING JAWS." FURTHER INFORMATION STATES THAT "THERE WERE NO CONSEQUENCES FOR THE PATIENT AND [THE DOCTOR] CONTINUED THE TRIPLE CORONARY ARTERY BYPASS SURGERY". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945522 ↗
• MalfunctionMay 17, 2023Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A TRIPLE CORONARY ARTERY BYPASS GRAFT BETWEEN ANTERIOR INTERVENTRICULAR ARTERY, WHEN ATTEMPTING TO REMOVE THE LEFT INTERNAL MAMMARY ARTERY, THE JAWS OF THE APPLIER MISALIGNED AND "ALTERED THE ARTERY". THE MISALIGNMENT OCCURRED ON THE FIRST CLIP OF THE APPLIER. ADDITIONAL INFORMATION STATES, "THE SURGEON SIMPLY SPECIFIED THAT THE ARTERY WAS DAMAGED, WITHOUT FURTHER DETAILS. IN TOTAL FOR THIS INTERVENTION WE RECOVERED 5 PLIERS, 2 FROM LOT 06D1517606 (LOT ASSOCIATED WITH THE INJURED ARTERY), 1 FROM LOT 562472-029, 1 FROM LOT 316340 AND 1 FROM LOT 06C1400093. ACCORDING TO THE SURGEON, NONE OF THE FORCEPS GAVE SATISFACTION, WITH CROSSING JAWS." FURTHER INFORMATION STATES THAT "THERE WERE NO CONSEQUENCES FOR THE PATIENT AND [THE DOCTOR] CONTINUED THE TRIPLE CORONARY ARTERY BYPASS SURGERY". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16945481 ↗
• MalfunctionMay 16, 2023Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A TRIPLE CORONARY ARTERY BYPASS GRAFT BETWEEN ANTERIOR INTERVENTRICULAR ARTERY, WHEN ATTEMPTING TO REMOVE THE LEFT INTERNAL MAMMARY ARTERY, THE JAWS OF THE APPLIER MISALIGNED AND "ALTERED THE ARTERY". THE MISALIGNMENT OCCURRED ON THE FIRST CLIP OF THE APPLIER. ADDITIONAL INFORMATION STATES, "THE SURGEON SIMPLY SPECIFIED THAT THE ARTERY WAS DAMAGED, WITHOUT FURTHER DETAILS. IN TOTAL FOR THIS INTERVENTION WE RECOVERED 5 PLIERS, 2 FROM LOT 06D1517606 (LOT ASSOCIATED WITH THE INJURED ARTERY), 1 FROM LOT 562472-029, 1 FROM LOT 316340 AND 1 FROM LOT 06C1400093. ACCORDING TO THE SURGEON, NONE OF THE FORCEPS GAVE SATISFACTION, WITH CROSSING JAWS." THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942679 ↗