LIGACLIP MSM20Recalls & reported problems

Summary

The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 10705036002505), received between Dec 20, 2017 and Aug 12, 2026 — classified as 1 injury, 151 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (97 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 152 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Failure to Form Staple; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222283 ↗
• MalfunctionAug 12, 2026Failure to Form Staple; Insufficient Device Problem Information

  It was reported that when being used in breast cases by surgeon. he feels that the clip applier is "Misfiring". He feels that the clips are not forming properly. There have been no patient injuries/problems, this is precautionary. No surgical delay or patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222281 ↗
• MalfunctionMay 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, CLIP APPLIERS NOT WORKING. SPOKE WITH SURGEON AND HE SAID WHILE DEPLOYING THE CLIPS THEY COME OUT TOO FAST OR DON'T STAY AFTER BEING CLIPPED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331202 ↗
• MalfunctionMay 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, CLIP APPLIERS NOT WORKING. SPOKE WITH SURGEON AND HE SAID WHILE DEPLOYING THE CLIPS THEY COME OUT TOO FAST OR DON'T STAY AFTER BEING CLIPPED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331178 ↗
• MalfunctionMay 28, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THAT CLIPS NOT RELOADING CORRECTLY. CLIPS WOULD JUST FALL OUT. NO DELAY OR PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25321709 ↗
• InjuryMay 20, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIP ¿JAMMED¿ WHILE FIRING ON TISSUE. DEVICE WAS REPLACED WITH LIKE DEVICE AND CASE WAS COMPLETED. SURGEON STATED THERE WAS DAMAGE TO THE VESSEL THAT THE DEVICE WAS BEING APPLIED TO. HE USED SURGICAL INTERVENTION TO REPAIR THE DAMAGE CAUSED BY THE DEVICE. THE SPECIFIC TECHNIQUE USED TO REPAIR THE DAMAGE IS NOT CONFIRMED BUT BELIEVED TO BE A SUTURE REPAIR TECHNIQUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25234562 ↗
• MalfunctionMay 7, 2026Delivered as Unsterile Product; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT HOSPITAL EMPLOYEE CLAIMS PACKAGE WAS CONTAMINATED AND SOME OF THE TYVEK APPEARED TO BE PEELING BACK AT THE EDGES OF THE RIGID BLISTER PACK. IT APPEARS THAT THE PRELOADED CLIP BECAME DISLODGED FROM THE JAWS OF THE APPLIER. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114898 ↗
• MalfunctionApr 21, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP DID NOT CLOSE PROPERLY AND WERE SCISSORING. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941531 ↗
• MalfunctionJan 8, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIP TRAUMATIZES THE VESSEL WHEN IT IS CLOSED, CAUSING DAMAGE TO THE PATIENT WHERE THERE HAD BEEN NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24010551 ↗
• MalfunctionJan 8, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIP TRAUMATIZES THE VESSEL WHEN IT IS CLOSED, CAUSING DAMAGE TO THE PATIENT WHERE THERE HAD BEEN NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24010538 ↗
• MalfunctionDec 11, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIPS "TOOK OFF" BUT REMAINED OPENED, WERE NOT CLOSED. USE OF ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777995 ↗
• MalfunctionDec 11, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIPS "TOOK OFF" BUT REMAINED OPENED, WERE NOT CLOSED. USE OF ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777858 ↗
• MalfunctionNov 24, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A WHITE RESIDUE AND WATER-SPOT APPEARANCE WAS OBSERVED WITHIN THE STERILE PACKAGING ON THE INSTRUMENT. THE HCP¿S HAD CONCERNS ABOUT STERILITY OF THE PRODUCT AND SAFETY OF THE RESIDUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638840 ↗
• MalfunctionOct 28, 2025Mechanical Jam; Mechanics Altered; Mechanical Jam; Mechanics Altered

  IT WAS REPORTED THAT DURING FIRST AXILLARY LYMPH NODE DISSECTION CASE THE SURGEON USED THE MSM20 CLIPS TO CLIP THE AXILLARY VEIN. AFTER A FEW CLIPS FIRED, THE DEVICE DID NOT RELOAD THE CLIPS AND IT ENDED UP LACERATING/CUTTING THE AXILLARY VEIN. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

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

  MAUDE report 23402011 ↗
• MalfunctionSep 15, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIPS DID NOT CLOSED AFTER A FEW USES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052995 ↗
• MalfunctionSep 15, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLIP TWISTED CONSEQUENTLY SO THAT THE TISSUE WAS NOT CLIPPED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052577 ↗
• MalfunctionJun 19, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CLAMP DID NOT WORK WELL, THE CLIPS DID NOT CLOSE ENOUGH. THE BLOCK TEAM HAD TO TAKE ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293246 ↗
• MalfunctionJun 11, 2025Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A VASCULAR PROCEDURE THE DEVICE WAS USED DURING A VESSEL SKELETANIZATION FOR ADJUNCTIVE HEMOSTASIS, BUT THE STAPLER WOULD NOT DEPLOY WELL FORMED CLIPS. THE DEVICE JAMMED. SURGEON WAS COMPELLED TO USE ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE SURGERY WAS DELAYED 3 MINUTES. 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 22182933 ↗
• MalfunctionJun 10, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WERE LOOSE CLIPS WHEN APPLYING. SOME FALLING OUT¿..VERY GENERIC FEEDBACK AND NO SPECIFIC DETAILS. NO SURGICAL ISSUES AS A RESULT. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177863 ↗
• MalfunctionJun 10, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WERE LOOSE CLIPS WHEN APPLYING. SOME FALLING OUT¿..VERY GENERIC FEEDBACK AND NO SPECIFIC DETAILS. NO SURGICAL ISSUES AS A RESULT. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177856 ↗
• MalfunctionMay 1, 2025Mechanical Problem; Failure to Form Staple; Mechanics Altered; Mechanical Problem; Failure to Form Staple; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, NOT LOCKING DOWN AFTER USING THE LAST CLIP AND THIS HAD LED TO DAMAGED VESSELS. NO PATIENT HARM WAS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21943810 ↗
• MalfunctionJan 29, 2025Failure to Form Staple; Failure to Form Staple

  USER FACILITY MEDWATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264780 ↗
• MalfunctionNov 19, 2024Mechanical Jam; Mechanics Altered; Mechanical Jam; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FIRST CLIP WOULD FIRE, BUT THEN THE NEXT CLIP WOULD NOT AUTO LOAD INTO THE APPLIER SPACE WHERE IT SHOULD. THIS CAUSED THE VESSEL LOOP TO BE CUT. CLIP APPLIER REMOVED FROM STERILE FIELD. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727607 ↗
• MalfunctionNov 19, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIP WAS MALFORMED AT THE FIRST SHOT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724399 ↗
• MalfunctionOct 30, 2024Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A CARDIOVASCULAR SURGERY, THE CLIP WAS MALFORMED IN USE. THE DEVICE TRIED TO BE DEPLOYED BUT IT DID NOT WORK. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570697 ↗