LIGACLIP ER420Recalls & reported problems

Summary

The FDA's MAUDE database contains 653 adverse event reports that list this exact device (DI 10705036012597), received between Feb 19, 2014 and Aug 27, 2026 — classified as 21 injuries, 632 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (536 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 653 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Failure to Form Staple; Mechanical Jam

  It was reported that during an Unknown procedure that the clip applier was inserted into the patient and clips were deployed onto the target tissue as intended. After several clips had been deployed, the device jaws did not load the subsequent clip and the device was closed without a clip. Being mindful to fully depress and let the jaws open, we tried to load and fire a clip multiple times without success. There were still clips in the chamber, but they weren't loading in the jaws. Delay of case, but no patient harm. New clip applier was pulled to finish the case. There was 5mins of surgical delay was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50475141 ↗
• MalfunctionAug 27, 2026Failure to Form Staple; Mechanical Jam

  It was reported that during an Unknown procedure that the clip applier was inserted into the patient and clips were deployed onto the target tissue as intended. After several clips had been deployed, the device jaws did not load the subsequent clip and the device was closed without a clip. Being mindful to fully depress and let the jaws open, we tried to load and fire a clip multiple times without success. There were still clips in the chamber, but they weren't loading in the jaws. Delay of case, but no patient harm. New clip applier was pulled to finish the case. There was 5mins of surgical delay was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50475138 ↗
• MalfunctionAug 27, 2026Failure to Form Staple; Mechanical Jam

  It was reported that during an Unknown procedure that the clip applier was inserted into the patient and clips were deployed onto the target tissue as intended. After several clips had been deployed, the device jaws did not load the subsequent clip and the device was closed without a clip. Being mindful to fully depress and let the jaws open, we tried to load and fire a clip multiple times without success. There were still clips in the chamber, but they weren't loading in the jaws. Delay of case, but no patient harm. New clip applier was pulled to finish the case. There was 5mins of surgical delay was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50475125 ↗
• MalfunctionAug 25, 2026Mechanical Problem; Failure to Fire

  It was reported that during an Unknown procedure the 2 jaws of the staples intersect during installation when tightening the handle making stapling impossible. Device change with another lab. No consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50428907 ↗
• MalfunctionAug 11, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50212397 ↗
• MalfunctionJul 21, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25894253 ↗
• MalfunctionJul 8, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25748268 ↗
• MalfunctionJun 23, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIPS WERE FOLDING OVER ONE ANOTHER, NOT STAYING ON STAPLE LINE, HAVING ISSUES RELOADING ONTO TRACK. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

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

  MAUDE report 25598239 ↗
• MalfunctionJun 16, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE THE DEVICE MISFIRED, AND THE CLIPS THAT WERE DEPLOYED WERE FOUND TO BE UNCLAMPED PRIOR TO ACTIVATION OF THE CLIPPER. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25521131 ↗
• MalfunctionJun 4, 2026Failure to Form Staple

  IT WAS REPORTED THAT, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHEN A CLIP WAS APPLIED, IT WAS NOT PROPERLY DEPLOYED, AND SCISSORING OCCURRED AT THE TIP. 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 25400088 ↗
• MalfunctionMay 5, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DOCTOR INDICATES THAT WHEN USING THE ER420 DEVICE, THE METAL CLIPS DID NOT FORM CORRECTLY. ON THE CONTRARY, THE CLIPS CRISSCROSSED WITH THE CONSEQUENT DANGER OF BEING ABLE TO TEAR THE ELEMENTS TO BE CLAMPED. THE EVENT OCCURS IN THE OPERATING ROOM WITH A PATIENT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25087546 ↗
• MalfunctionApr 24, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHILE LOADING THE DEVICE, THE CLIP DETACHED AFTER COMING INTO CONTACT WITH TISSUE, AND THEREFORE THE PRODUCT COULD NOT BE USED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24984156 ↗
• MalfunctionApr 21, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE REFERENCE PRODUCT ER420 DID NOT WORK PROPERLY. THE PAPERCLIPS DID NOT FINISH FORMING CORRECTLY AND WERE PARTIALLY OPEN. NO PATIENT CONSEQUENCE'S WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945169 ↗
• MalfunctionApr 3, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIPS SCISSORED WHEN FIRED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24782206 ↗
• MalfunctionApr 3, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIPS SCISSORED WHEN FIRED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24782145 ↗
• MalfunctionMar 31, 2026Failure to Form Staple

  IT WAS REPORTED THAT, DURING AN UNKNOWN LAPAROSCOPIC SURGERY, THE CLIP WAS UNFORMED AND POORLY ALIGNED SEVERAL TIMES DURING CLIPPING. THE USE WAS STOPPED. 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 24747965 ↗
• MalfunctionMar 30, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC SIGMOIDECTOMY OPERATION, BLEEDING OCCURRED WHICH WAS TO BE STOPPED USING A CLIP APPLICATOR. HOWEVER, SOME CLIPS FAILED TO CLOSE PROPERLY DURING APPLICATION, NECESSITATING THE USE OF A NEW INSTRUMENT TO FINISH THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

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

  MAUDE report 24736778 ↗
• MalfunctionMar 3, 2026Mechanical Problem; Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLIP APPLIER WAS OVERLAPPING CAUSING BLEEDING ON THE STAPLE LINE AND NOT PERFORMING PROPERLY. THE PROCEDURE WAS DELAYED BY 3 MINUTES AND NO PATIENT CONSEQUENCES WERE REPORTED.

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

  MAUDE report 24501140 ↗
• MalfunctionMar 2, 2026Mechanical Problem; Failure to Form Staple

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE JAWS WERE MISALIGNED, AND THE CLIP WAS UNFORMED. 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 24484557 ↗
• MalfunctionFeb 27, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, 2 CLIPS SCISSORED WHEN FIRED. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474498 ↗
• MalfunctionFeb 27, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, 2 CLIPS SCISSORED WHEN FIRED. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474322 ↗
• MalfunctionFeb 24, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY THE CLIP HAD PROBLEM WITH THE ALIGNMENT, IT IS OVERLAPPING AND NOT WELL FORMED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES, IF YES, NUMBER OF MINUTES: 3-4 MINUTES, ACTION TAKEN WHEN EVENT OCCURRED? OPEN A NEW ONE, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429995 ↗
• MalfunctionFeb 24, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY THE CLIP HAD PROBLEM WITH THE ALIGNMENT, IT IS OVERLAPPING AND NOT WELL FORMED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> YES, IF YES, NUMBER OF MINUTES: --> 3-4 MINUTES, ACTION TAKEN WHEN EVENT OCCURRED? --> OPEN A NEW ONE , WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429987 ↗
• MalfunctionFeb 24, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN LAP GASTRIC BYPASS THE APPLIER WAS NOT DELIVERING ANY CLIPS CORRECTLY. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429475 ↗
• MalfunctionFeb 23, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS ARE MISALIGNED AND DO NOT CLOSE PROPERLY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422547 ↗