LIGACLIP MCL20Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10705036002468), received between Dec 4, 2017 and Apr 24, 2026 — classified as 1 death, 2 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (42 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 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING KIDNEY TRANSPLANT PROCEDURE, THE SURGICAL TEAM ATTEMPTED TO USE THE CLIP HOWEVER, THE SURGEON OBSERVED THAT THE CLIP DID NOT LIGATE OR FUNCTION AS INTENDED. IT IS UNKNOWN WHETHER THERE WERE ANY PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984199 ↗
• MalfunctionApr 14, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, USE OF CLIP ON A PERI-PROSTHETIC FRACTURE APPROACH, AT THE TIME OF USE OF THE CLIPS, THE LATTER CUT THE TISSUES SEVERAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873424 ↗
• MalfunctionJan 23, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE USING AN ETHICON LARGE CLIP APPLIER TO CLIP A VEIN, AND IT ENDED UP TEARING THROUGH THE VEIN; THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24167089 ↗
• MalfunctionNov 24, 2025Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY (WHIPPLE) PROCEDURE, THE CLIP FAILED TO DEPLOY PROPERLY, RESULTING IN ADDITIONAL BLEEDING FROM THE PORTAL VEIN.

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

  MAUDE report 23638053 ↗
• MalfunctionOct 22, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN EXLAPAROTOMY WHIPPLE PROCEDURE, THE SALES REPRESENTATIVE REPORTED THAT THE CLIPS WERE NOT FORMING PROPERLY, AND SOME CLIPS WERE COMING OUT OF THE CLIP APPLIER. NO PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356648 ↗
• MalfunctionOct 20, 2025Failure to Form Staple; Firing Problem; Failure to Form Staple; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIP WASN'T FIRING WELL. AFTER FIRING A FEW TIMES, THE WINGS WERE NOT CLOSED AND FELT TOO TOUGH TO CLOSE. BUT THE PATIENTS HAD NO PROBLEM ON THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336559 ↗
• MalfunctionJul 23, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY. AFTER CLAMPED THE CLIPS AND CLIP COULD NOT CLOSE. CHANGED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED, NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574396 ↗
• MalfunctionJul 2, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A PANNICULECTOMY THE LARGE CLIP APPLIERS THAT THE CLIP DID NOT FORM CORRECTLY. NO SURGICAL DELAY WAS REPORTED. NO PATIENT HARM WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382681 ↗
• MalfunctionMay 1, 2025Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CLIPS SLID OFF VESSEL. HEMORRHAGE, STRESS, AND INCREASED OPERATIVE TIME AND ANESTHESIA DURATION. ANOTHER DEVICE WAS USED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21945121 ↗
• MalfunctionFeb 24, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CLIPS WERE NOT DEPLOYED ON TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21453207 ↗
• MalfunctionJan 30, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A THYROID PROCEDURE, CLIPS WERE SCISSORING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276756 ↗
• MalfunctionJan 30, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A THYROID PROCEDURE, CLIPS WERE SCISSORING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276718 ↗
• MalfunctionNov 19, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE ONLY RELEASED ONE CLIP AND DIDN'T CLIP PROPERLY. REMOVED AND OPENED ANOTHER DEVICE. PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727313 ↗
• MalfunctionSep 26, 2024Failure to Form Staple; No Apparent Adverse Event; Firing Problem; Failure to Form Staple; No Apparent Adverse Event; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CLIP APPLIER IS NOT CLOSING EASILY. SOME STAPLES DIDN'T CLOSE PROPERLY. PLACENTA PREVIA BLEEDING. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309560 ↗
• MalfunctionSep 26, 2024Failure to Form Staple; No Apparent Adverse Event; Firing Problem; Failure to Form Staple; No Apparent Adverse Event; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CLIP APPLIER IS NOT CLOSING EASILY. SOME STAPLES DIDN'T CLOSE PROPERLY. PLACENTA PREVIA BLEEDING. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309512 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OPERATION TO AN PANNICULECTOMY PROCEDURE, THE PATIENT RETURNED TO THE ER WITH A BLEED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20145739 ↗
• MalfunctionJul 23, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, CLIP CAN NOT SECURE ON TISSUE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19809230 ↗
• MalfunctionJul 17, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING PANNICULECTOMY, A LARGE CLIP APPLIER WAS NOT CLIPPING VERY WELL. TRYING TO CLIP ONTO THE VESSEL AND CLIP WOULD NOT HOLD AND WAS FALLING OFF. WHEN FIRED, THE CLIP APPLIER WAS ROUGH, NOT SMOOTH. CASE COMPLETED WITH SAID DEVICE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19764327 ↗
• MalfunctionJul 17, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING PANNICULECTOMY, A LARGE CLIP APPLIER WAS NOT CLIPPING VERY WELL. TRYING TO CLIP ONTO THE VESSEL AND CLIP WOULD NOT HOLD AND WAS FALLING OFF. WHEN FIRED, THE CLIP APPLIER WAS ROUGH, NOT SMOOTH. CASE COMPLETED WITH SAID DEVICE. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19764317 ↗
• MalfunctionJun 17, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A CARCINOMATOSIS PROCEDURE, DOESN¿T CLOSE WELL. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547879 ↗
• MalfunctionJun 17, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A CARCINOMATOSIS PROCEDURE, DOESN¿T CLOSE WELL. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547878 ↗
• MalfunctionMar 5, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LIVER RESECTION, CLIPS DID NOT CLOSE PROPERLY. NO PATIENT IMPACT OR SURGERY DELAY REPORTED. OPERATION WAS FINISHED WITH NEW INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837848 ↗
• MalfunctionFeb 22, 2024Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A FREE FLAP RECONSTRUCTION PROCEDURE, JAW CUTTING OCCURRED. USED ANOTHER CLIP TO OCCLUDE VESSEL. MINIMAL BLEEDING AND NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18763011 ↗
• InjurySep 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST OP TO AN UNKNOWN PROCEDURE, THE PATIENT HAS PAIN AND INFLAMMATION IN THE NECK AND ON THE RIGHT SIDE 24/7 HAS TO TAKE PAIN MEDICATION FOR PAIN.

  Patient problems: Inflammation; Pain

  MAUDE report 17827143 ↗
• MalfunctionAug 18, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICES WERE CROSS CLIPPING. NO OTHER INFORMATION COULD BE PROVIDED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573790 ↗