Endo Clip 176625Recalls & reported problems

Summary

The FDA's MAUDE database contains 768 adverse event reports that list this exact device (DI 10884521057845), received between Apr 12, 2016 and Sep 22, 2026 — classified as 1 death, 52 injuries, 715 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (402 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 768 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860261 ↗
• MalfunctionSep 21, 2026Mechanical Problem

  It was reported that during a laparoscopic procedure, while being used to apply clips to the cystic duct, the clips became deformed during attempted clipping despite no excessive force reportedly being applied by the surgeon, and the issue recurred during severalattempts. The surgeon was able to squeeze the handle. A different product was used to complete the procedure. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841071 ↗
• MalfunctionAug 28, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50498843 ↗
• MalfunctionAug 27, 2026Detachment of Device or Device Component

  According to the reporter, the knob fell off. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50486708 ↗
• MalfunctionAug 27, 2026Mechanics Altered

  It was reported that the device experienced delayed deployment.

  Patient problems: Insufficient Information

  MAUDE report 50470230 ↗
• MalfunctionJul 28, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50061270 ↗
• MalfunctionJul 20, 2026Mechanics Altered

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25874972 ↗
• InjuryJul 16, 2026Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING CLIPPING OF THE CYSTIC ARTERY, THE HANDLE OF THE CLIP APPLIER WAS NOT SQUEEZED, AND THE INITIAL FIRING FAILED TO DEPLOY A CLIP. UPON REPEAT ACTIVATION, THE FIRING MECHANISM ADVANCED WITHOUT DEPLOYING A CLIP, RESULTING IN TRANSECTION OF THE CYSTIC ARTERY AND SIGNIFICANT BLEEDING. ATTEMPTS TO FIRE THE CLIP APPLIER OUTSIDE THE PATIENT ALSO FAILED TO DEPLOY ANY CLIPS. THE MALFUNCTION CAUSED SIGNIFICANT BLOOD LOSS AND MASSIVE HEMORRHAGE, PROMPTED A CODE PROTOCOL, AND RESULTED IN THE PATIENT BEING ADMITTED TO THE ICU. IT WAS CONFIRMED THAT THE PATIENT IS DOING WELL WITH NO FURTHER COMPLICATIONS IN HOSPITAL AND HAS BEEN DISCHARGED HOME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25850113 ↗
• MalfunctionJul 15, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, THE DEFECTIVE CLIP APPLIER MISFIRED.

  Patient problems: Insufficient Information

  MAUDE report 25827898 ↗
• MalfunctionJul 6, 2026Mechanics Altered

  ACCORDING TO THE REPORTER DURING A PROCEDURE, AFTER REPEATED FIRING OF THE CLIPS, THE DEVICE COULD NO LONGER DEPLOY THE CLIPS IN THE LATER STAGE OF USE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 25727446 ↗
• MalfunctionJun 15, 2026Mechanical Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTROTOMY PROCEDURE, THE DEVICE HAD AN UNKNOWN ISSUE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE JAWS WOULD NOT CLOSE AND THE LOADING TRIGGER COULD NOT BE ACTUATED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513691 ↗
• MalfunctionMay 29, 2026Mechanical Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A GALLBLADDER PROCEDURE, THE CLIPS WERE CLOSING AT A DIAGONAL ANGLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25328040 ↗
• MalfunctionMay 29, 2026Mechanical Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A GALLBLADDER PROCEDURE, THE CLIPS WERE CLOSING AT A DIAGONAL ANGLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25327955 ↗
• MalfunctionApr 14, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, ON THE STAGE OF EXTRACTING THE GALLBLADDER, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND USAGE WAS DISCONTINUED BECAUSE THE CLIP WAS MISALIGNED DURING FIRING. THE MISALIGNED CLIP WAS COLLECTED AND THERE WAS NO PROBLEMS WITH THE NEW CLIP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872238 ↗
• MalfunctionApr 3, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE DID NOT CLOSE PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781749 ↗
• MalfunctionMar 26, 2026Mechanical Jam

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE CLIP APPLIER WAS INITIALLY WORKING, AND THEN IT STARTED TO JAM AND NOT BE USABLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24708230 ↗
• MalfunctionMar 19, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND THE JAWS WERE ABLE TO CLOSE, BUT THE CLIPS DID NOT FORM CORRECTLY. ANOTHER CLIP APPLIER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24645772 ↗
• MalfunctionFeb 27, 2026Detachment of Device or Device Component; Mechanics Altered

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC PROCEDURE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, BUT THE DEVICE MISFIRED. THE RING FROM THE CONNECTION OF THE HANDLE¿S BODY AND THE SHAFT ALSO DETACHED AND SHOT ACROSS THE ROOM. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470615 ↗
• MalfunctionFeb 25, 2026Break; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER SQUEEZING THE HANDLE, THE CLIPS WERE NOT LOADED WELL, AND THE LAUNCH PART WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 24444350 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THERE WERE NO INDICATIONS THAT THE CLIPS WERE MISPLACED OR MALFORMED. IT WAS STANDARDIZED TO DO A LEAKAGE CONTROL AND INSPECT THE CLIPS' PLACEMENT. THERE WAS NOTHING ABNORMAL DURING THE INITIAL SURGERY. DUE TO PROLONGED REHABILITATION POSTOPERATIVELY, THE PATIENT UNDERWENT EXTRA CONTROLS AND WAS DIAGNOSED WITH BILE LEAKAGE. THE EXTRA INTERVENTIONS CONSISTED OF PLACEMENT OF DRAINAGE, INTRAVENOUS ANTIBIOTICS, AND ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY (ERC). A PROLONGED HOSPITAL STAY WAS NEEDED.

  Patient problems: Biliary Leak; Tissue Breakdown

  MAUDE report 24398434 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THERE WERE NO INDICATIONS THAT THE CLIPS WERE MISPLACED OR MALFORMED. IT WAS STANDARDIZED TO DO A LEAKAGE CONTROL AND INSPECT THE CLIPS' PLACEMENT. THERE WAS NOTHING ABNORMAL DURING THE INITIAL SURGERY. DUE TO PROLONGED REHABILITATION POSTOPERATIVELY, THE PATIENT UNDERWENT EXTRA CONTROLS AND WAS DIAGNOSED WITH BILE LEAKAGE. THE EXTRA INTERVENTIONS CONSISTED OF PLACEMENT OF DRAINAGE, INTRAVENOUS ANTIBIOTICS, AND ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY (ERC). A PROLONGED HOSPITAL STAY WAS NEEDED.

  Patient problems: Biliary Leak; Tissue Breakdown

  MAUDE report 24394123 ↗
• MalfunctionFeb 19, 2026Material Deformation

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLIPS WERE SCISSORED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385878 ↗
• MalfunctionFeb 19, 2026Material Deformation

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A BARIATRIC PROCEDURE, WHILE IN THE STOMACH, THE CLIPS WERE SCISSORED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385871 ↗
• MalfunctionFeb 19, 2026Material Deformation

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLIPS WERE SCISSORED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385862 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THERE WERE NO INDICATIONS THAT THE CLIPS WERE MISPLACED OR MALFORMED. IT WAS STANDARDIZED TO DO A LEAKAGE CONTROL AND INSPECT THE CLIPS' PLACEMENT. THERE WAS NOTHING ABNORMAL DURING THE INITIAL SURGERY. DUE TO PROLONGED REHABILITATION POSTOPERATIVELY, THE PATIENT UNDERWENT EXTRA CONTROLS AND WAS DIAGNOSED WITH BILE LEAKAGE. THE EXTRA INTERVENTIONS CONSISTED OF PLACEMENT OF DRAINAGE, INTRAVENOUS ANTIBIOTICS, AND ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY (ERC). A PROLONGED HOSPITAL STAY WAS NEEDED.

  Patient problems: Biliary Leak; Tissue Breakdown

  MAUDE report 24376343 ↗