LIGACLIP MCM20Recalls & reported problems

Summary

The FDA's MAUDE database contains 308 adverse event reports that list this exact device (DI 10705036002475), received between Sep 27, 2017 and Sep 30, 2026 — classified as 22 injuries, 286 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (181 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 308 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Difficult to Open or Close

  It was reported that during a bowel resection the open clip applier jaws stuck on tissue after deployment of clip. It was reported that this happened multiple times. The RN reported that they did try to dry fire clips to correct the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946508 ↗
• MalfunctionSep 17, 2026Failure to Form Staple

  It was reported that during an open surgery procedure, the vascular ligation clip applier failed to dispense the clip as intended. The device was replaced with another unit and the procedure was completed successfully. No Are there any reported cases of harm from patients or users? Unknown Was there a significant delay? No

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805944 ↗
• MalfunctionAug 18, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299140 ↗
• MalfunctionJul 9, 2026Mechanics Altered

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

  MAUDE report 25770975 ↗
• MalfunctionJul 6, 2026Mechanics Altered; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, MEDIUM SIZE LIGA CLIPS ARE TEARING/SHEARING THE VESSEL AS THE CLIPS ARE APPLIED. SMALL CLIPS ARE FINE, AND THEY DON'T USE LARGE CLIPS FOR ENT. THIS IS ALSO AN ISSUE IN ANOTHER HOSPITAL- AND THEY USE A MANUAL CLIP APPLICATOR IN THAT. NO PATIENT CONSEQUENCES WERE REPORTED.

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

  MAUDE report 25717784 ↗
• MalfunctionJul 6, 2026Mechanics Altered; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN ENT PROCEDURE, THAT MEDIUM SIZE LIGA CLIPS ARE TEARING/SHEARING THE VESSEL AS THE CLIPS ARE APPLIED. SMALL CLIPS ARE FINE, AND THEY DON'T USE LARGE CLIPS FOR ENT. NO PATIENT CONSEQUENCES WERE REPORTED.

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

  MAUDE report 25717599 ↗
• MalfunctionJul 1, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIP WILL FALL. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680683 ↗
• MalfunctionJun 10, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, INCOMPLETE VESSEL LIGATION WAS NOTED DURING SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462285 ↗
• MalfunctionMay 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, INTRAOPERATIVE USE OF A FIRST CLIP APPLICATOR. THE SURGEON NOTES THAT WHEN THE TITANIUM CLIPS ARE APPLIED, THEY CLOSE POORLY. INDEED, EACH CLIP OF THE CLAMP CLOSES BY CROSSING EACH OTHER. A SECOND APPLICATOR (SAME LOT NUMBER) IS GIVEN TO THE OPERATOR AS A REPLACEMENT AND THE SAME PROBLEM OCCURS. TITANIUM CLIPS CLOSE WHEN CROSSING, WHICH CAN DAMAGE TISSUE. AN APPLICATOR FROM ANOTHER BATCH WAS GIVEN TO THE SURGEON TO COMPLETE THE PROCEDURE, AND THERE WAS NO LONGER A PROBLEM CLOSING THE NEW CLIPS. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334705 ↗
• MalfunctionMay 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, INTRAOPERATIVE USE OF A FIRST CLIP APPLICATOR. THE SURGEON NOTES THAT WHEN THE TITANIUM CLIPS ARE APPLIED, THEY CLOSE POORLY. INDEED, EACH CLIP OF THE CLAMP CLOSES BY CROSSING EACH OTHER. A SECOND APPLICATOR (SAME LOT NUMBER) IS GIVEN TO THE OPERATOR AS A REPLACEMENT AND THE SAME PROBLEM OCCURS. TITANIUM CLIPS CLOSE WHEN CROSSING, WHICH CAN DAMAGE TISSUE. AN APPLICATOR FROM ANOTHER BATCH WAS GIVEN TO THE SURGEON TO COMPLETE THE PROCEDURE, AND THERE WAS NO LONGER A PROBLEM CLOSING THE NEW CLIPS. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334647 ↗
• MalfunctionMay 7, 2026Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT, DURING CARDIOVASCULAR SURGERY, AFTER SEVERAL FIRINGS WITH TWO DEVICES IN A ROW, THE CLIP COULD NOT BE DEPLOYED. THE CLIPS COULD NOT CLAMP THE TISSUE (POSSIBLE SCISSORING). 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 25117219 ↗
• MalfunctionMay 7, 2026Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT, DURING CARDIOVASCULAR SURGERY, AFTER SEVERAL FIRINGS WITH TWO DEVICES IN A ROW, THE CLIP COULD NOT BE DEPLOYED. THE CLIPS COULD NOT CLAMP THE TISSUE (POSSIBLE SCISSORING). 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 25117202 ↗
• MalfunctionMay 7, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, THE SURGEON MENTIONED THAT THESE PARTICULAR CLIP APPLIERS CUT THE VEIN INSTEAD OF CLIPPING. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25114254 ↗
• MalfunctionMay 4, 2026Failure to Form Staple; Mechanics Altered; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE HEPATECTOMY SURGERY. MISFIRING DURING VESSEL SEALING. CAUSES INCOMPLETE PATIENT VESSEL TRANSECTION AND CLAMPING, INCREASING INTRAOPERATIVE BLEEDING. SUTURE WAS USED TO OVERSEW. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

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

  MAUDE report 25073361 ↗
• MalfunctionApr 13, 2026Failure to Form Staple; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHEN THE CLIP WAS IMPLANTED ON THE BLOOD VESSEL, IT HAD TORN THE VESSEL WALL. NO PATIENT CONSEQUENCES WERE REPORTED.

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

  MAUDE report 24865109 ↗
• MalfunctionApr 13, 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 24859459 ↗
• MalfunctionApr 9, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIPS DO NOT FIT ON THE CLIPPED FABRIC. THE CLIPS FALL BY THEMSELVES, WITHOUT ANY PARTICULAR STRESS. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24835760 ↗
• MalfunctionApr 6, 2026Failure to Form Staple; Failure to Fire; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, FAILURE OF CLIP DEPLOYMENT. SURGEONS EXPERIENCED CRISS-CROSSED CLIPS; CLIPS NOT DEPLOYED OR FAILED TO CLOSE PROPERLY AND CLIPS CUTTING ON THE VESSELS. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794203 ↗
• MalfunctionApr 6, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A PLASTIC SURGICAL PROCEDURE IN WHICH A LARGE FLAP WAS PRESERVED, CLIPS WERE PLACED ON A BLOOD VESSEL, BUT THE CLIPS DISLODGED. THIS CAUSED BLEEDING WITH AN IMMEDIATE BLOOD LOSS OF 200 ML. A REUSABLE CLIP APPLIER FROM ANOTHER SUPPLIER WAS OPENED, AFTER WHICH THE CLIPS REMAINED IN PLACE AND THE PROCEDURE COULD BE CONTINUED. THE POSTOPERATIVE COURSE WAS UNCOMPLICATED. THE SURGERY WAS DELAYED BY 15 MINUTES AND COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24793680 ↗
• MalfunctionMar 31, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHEN OPENING THE PROTECTIVE BAG, THE CANOPY STAFF FINDS THE DIRECT PACKAGING OF THE PRODUCT DAMAGED WITH A HOLE, SO IT IS NOT POSSIBLE TO USE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747391 ↗
• MalfunctionMar 31, 2026Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING CABG PROCEDURE, DURING THE DISSECTION OF THE SAPHENOUS VEINS, THE CLIP USED FOR SCISSOR CROSSING DID NOT CONSISTENTLY ENGAGE. SOME CLIPS SECURED PROPERLY WHILE OTHERS FAILED TO HOLD. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746456 ↗
• MalfunctionMar 26, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHEN THEY PLACE A CLIP ON THE VESSEL IT CUTS THE VESSEL IN HALF. NO ADVERSE IMPACT PATIENT/USER.

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

  MAUDE report 24702542 ↗
• MalfunctionMar 26, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHEN THEY PLACE A CLIP ON THE VESSEL IT CUTS THE VESSEL IN HALF. NO ADVERSE IMPACT PATIENT/USER.

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

  MAUDE report 24702517 ↗
• MalfunctionMar 26, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHEN THEY PLACE A CLIP ON THE VESSEL IT CUTS THE VESSEL IN HALF. NO ADVERSE IMPACT PATIENT/USER.

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

  MAUDE report 24702493 ↗
• MalfunctionMar 25, 2026Failure to Form Staple; Failure to Fire; Mechanics Altered

  IT WAS REPORTED THAT THERE WAS A FAILURE OF CLIP DEPLOYMENT. SURGEON EXPERIENCED CRISS-CROSSED CLIPS; CLIPS NOT DEPLOYED OR FAILED TO CLOSE PROPERLY AND CLIPS CUTTING ON THE VESSELS. IT IS ONLY EVEN ONE OR TWO OF THE CLIPS OUT OF THE 20. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694184 ↗