LIGACLIP MCM30Recalls & reported problems

Summary

The FDA's MAUDE database contains 236 adverse event reports that list this exact device (DI 10705036002482), received between Dec 13, 2017 and Sep 10, 2026 — classified as 1 death, 7 injuries, 228 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (143 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 236 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Difficult to Open or Close; Noise, Audible

  It was reported that during an Unknown procedure the device malfunction during use. The device failed to release after clip deployment and produced an unusual sound during operation. The device was replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713671 ↗
• MalfunctionJul 6, 2026Failure to Fire; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THAT TWO ETHICON MCM30 CLIP APPLIERS MALFUNCTIONED, THESE CLIPS CAME FROM THERE MEDLINE DIEP PACK. IT WAS REPORTED THAT WHEN USED ON A VESSEL, NO CLIP WAS DEPLOYED AND THAT THE JAWS OF THE CLIP APPLIER CUT THE VESSEL RATHER THAN PROPERLY DEPLOYING A CLIP. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 25717994 ↗
• MalfunctionJun 18, 2026Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE CLIPPED VESSEL; THE JAWS DID NOT RELEASE-STUCK IN THE CLOSED POSITION-NEEDED TO PULL APART. REPLACED WITH ANOTHER CLIP APPLIER -SAME ISSUE AND SAME LOT. REPLACED WITH ANOTHER CLIP APPLIER -DIFFERENT LOT NUMBER AND IT WORKED. UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT CONSEQUENCES WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548168 ↗
• MalfunctionJun 18, 2026Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE CLIPPED VESSEL; THE JAWS DID NOT RELEASE-STUCK IN THE CLOSED POSITION-NEEDED TO PULL APART. REPLACED WITH ANOTHER CLIP APPLIER -SAME ISSUE AND SAME LOT. REPLACED WITH ANOTHER CLIP APPLIER -DIFFERENT LOT NUMBER AND IT WORKED. UNKNOWN IF THERE WAS ANY SURGICAL DELAY. PATIENT CONSEQUENCES WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25548150 ↗
• MalfunctionMay 26, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE TUMOR RESECTION SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25283850 ↗
• MalfunctionApr 6, 2026Mechanical Problem; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE MULTI-CLIP APPLIER TIPS WERE CROSSING CAUSING A MISFIRE OF THE CLIPS. VESSELS WERE BEING CLIPPED BUT NOT SEALED DUE TO THE MALFUNCTION OF THE CLIP APPLIER. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794166 ↗
• MalfunctionMar 30, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718234 ↗
• MalfunctionFeb 20, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, IT WAS FOUND THAT THE CLIP FELL OFF DURING THE PROCEDURE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405626 ↗
• MalfunctionFeb 20, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNK 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 24405477 ↗
• InjuryFeb 9, 2026Mechanical Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE MISFIRED. THE PATIENT EXPERIENCED BLOOD LOSS REQUIRING TRANSFUSION, A RETURN TO THE OPERATING ROOM, AND A PROLONGED HOSPITAL STAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24292860 ↗
• MalfunctionJan 28, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE MEDIUM CLIP DEPLOYED, THEN 2ND CLIP ATTEMPTED, BUT THE TIPS CRISSCROSSED AND THE SURGEON HAD TO PULL THE APPLIER OUT. NO ADVERSE IMPACT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199712 ↗
• MalfunctionJan 22, 2026Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE NAIL IS STUCK AND THE NAIL IS CROOKED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152583 ↗
• MalfunctionDec 30, 2025Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHILE FIRING THE MCM 30 PINS FORMED ARE NOT IN PROPER SHAPE. VESSELS BLEEDING AFTER FIRING ALSO IN PRIMARY CLOSURE CASE IN GYNAECOLOGY ONCO. SURGEON DOES 3-4 FIRING BUT BLEEDING WAS THERE CONTINUOUS. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23922286 ↗
• MalfunctionDec 29, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE MATERIAL WAS DEFECTIVE DURING USE, THE CLIPS DID NOT FIX. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23909001 ↗
• MalfunctionOct 28, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE THERE WAS A MCM30 PACKAGE IS OPEN, NOT STERILE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23402079 ↗
• MalfunctionSep 15, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIP TIP CROSS DURING FIRING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23053569 ↗
• MalfunctionJul 10, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE MCM30 PRODUCT DIDN'T CLIP THE VESSEL BUT INSTEAD IT CUT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468361 ↗
• MalfunctionJul 10, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE MCM30 CLIP DID NOT CLIP THE VESSEL, INSTEAD IT HAS CUT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468173 ↗
• MalfunctionJul 7, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS DEFORMATION OF CLIPS. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412346 ↗
• MalfunctionJun 3, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A THYROID PROCEDURE AS SOON AS THE SURGEON DEPLOYED THE MCM30 CLIPS, THEY WEREN'T CLIPPING AT ALL. THEY TRIED A FEW TIMES BUT NONE OF THEM WERE WORKING. A NEW DEVICE WAS OPENED, THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131226 ↗
• MalfunctionMay 1, 2025Mechanical Jam; Mechanics Altered; No Apparent Adverse Event; Firing Problem; Mechanical Jam; Mechanics Altered; No Apparent Adverse Event; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FIRST CLIP WAS VERY STIFF. SUBSEQUENT CLIPS WERE NOT ALL FIRED SMOOTHLY. ON SEVERAL OCCASIONS, THE BRANCH REMAINED EMPTY BECAUSE THE CLIPS HAD DIFFICULTY SLIDING DOWN, AND ON SEVERAL OCCASIONS, A VESSEL WAS TRAPPED BETWEEN THE BRANCHES INSTEAD OF BEING CLIPPED. THIS DAMAGED THE VESSEL AND CAUSED BLEEDING, NECESSITATING LIGATION. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED FINISHED THE PROCEDURE WITH A NEW INSTRUMENT.

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

  MAUDE report 21945103 ↗
• MalfunctionMay 1, 2025Mechanical Jam; Mechanics Altered; No Apparent Adverse Event; Firing Problem; Mechanical Jam; Mechanics Altered; No Apparent Adverse Event; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FIRST CLIP WAS VERY STIFF. SUBSEQUENT CLIPS WERE NOT ALL FIRED SMOOTHLY. ON SEVERAL OCCASIONS, THE BRANCH REMAINED EMPTY BECAUSE THE CLIPS HAD DIFFICULTY SLIDING DOWN, AND ON SEVERAL OCCASIONS, A VESSEL WAS TRAPPED BETWEEN THE BRANCHES INSTEAD OF BEING CLIPPED. THIS DAMAGED THE VESSEL AND CAUSED BLEEDING, NECESSITATING LIGATION. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED FINISHED THE PROCEDURE WITH A NEW INSTRUMENT.

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

  MAUDE report 21945086 ↗
• MalfunctionMay 1, 2025Mechanical Jam; Mechanics Altered; No Apparent Adverse Event; Firing Problem; Mechanical Jam; Mechanics Altered; No Apparent Adverse Event; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FIRST CLIP WAS VERY STIFF. SUBSEQUENT CLIPS WERE NOT ALL FIRED SMOOTHLY. ON SEVERAL OCCASIONS, THE BRANCH REMAINED EMPTY BECAUSE THE CLIPS HAD DIFFICULTY SLIDING DOWN, AND ON SEVERAL OCCASIONS, A VESSEL WAS TRAPPED BETWEEN THE BRANCHES INSTEAD OF BEING CLIPPED. THIS DAMAGED THE VESSEL AND CAUSED BLEEDING, NECESSITATING LIGATION. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED FINISHED THE PROCEDURE WITH A NEW INSTRUMENT.

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

  MAUDE report 21945085 ↗
• MalfunctionApr 22, 2025Mechanics Altered; No Apparent Adverse Event; Mechanics Altered; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNKNOWN PLASTIC SURGERY PROCEDURE, CLIP CUT THE VESSEL.

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

  MAUDE report 21882391 ↗
• MalfunctionMar 20, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, INSIDE PACKAGE TEAR WHILE OPENING MAKING IT NON-STERILE AND UNABLE TO BE USED. THERE WAS NO PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655395 ↗