Endo Universal 65 173054Recalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 10884521070530), received between Jul 30, 2017 and May 4, 2026 — classified as 4 injuries, 134 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (94 reports).

4 other recalls cover devices cleared under the same FDA submission (K912097); they may or may not involve this specific model.

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 138 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HANDLE NO LONGER CLOSED AFTER THE FIRST STAPLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073521 ↗
• MalfunctionMay 4, 2026Misfire; No Apparent Adverse Event; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE HANDLE NO LONGER CLOSES AFTER THE APPLICATION OF THE FIRST STAPLE. ANOTHER DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073518 ↗
• MalfunctionFeb 17, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE STAPLING THE MESH, THE STAPLER STOPPED FUNCTIONING AFTER SEVERAL USES AND COULD NO LONGER BE FIRED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373617 ↗
• MalfunctionJan 29, 2026Break; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE STAPLER WOULD NOT FIRE AND THE HANDLE CAME APART WHILE SURGEON TRIED TO MAKE IT WORK.

  Patient problems: Insufficient Information

  MAUDE report 24216935 ↗
• MalfunctionJan 26, 2026Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTOPEXY MESH FIXATION, THE HANDLE BROKE INTO PIECES WHEN THE SURGEON ATTEMPTED TO ACTIVATE IT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176801 ↗
• MalfunctionDec 26, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE HERNIA STAPLER COULD NOT BE FIRED. THE SURGEON TOOK A SECOND STAPLER TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898465 ↗
• MalfunctionJul 7, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PRE-OPERATIVELY, THE MANUAL HANDLE COULD NOT BE ACTIVATED. THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE WHEN THE ISSUE OCCURRED. ANOTHER HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22425522 ↗
• MalfunctionJun 5, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, THE STAPLER DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22149855 ↗
• MalfunctionMay 27, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE, THE STAPLER WAS APPLIED FOR MESH FIXATION WHEN IT BLOCKED AFTER FOUR FIRINGS. THE ISSUE WAS RESOLVED BY USING ANOTHER STAPLER TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092771 ↗
• MalfunctionMar 5, 2025Display or Visual Feedback Problem; Failure to Fire; Display or Visual Feedback Problem; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE FIRE INITIALLY, BUT AFTER FIVE TO TEN STAPLES THE STAPLER JAMMED AND DID NOT FIRE OUT. ADDITIONALLY, IT WOULD PUT OUT TWO STAPLES AT A TIME EVERY ONCE IN A WHILE. THIS ISSUE OCCURRED WITH A 4 MILLIMETER (MM) AND 4.8 MM STAPLE. TO RESOLVE THE ISSUE, A THIRD STAPLER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21532046 ↗
• MalfunctionMar 5, 2025Display or Visual Feedback Problem; Failure to Fire; Display or Visual Feedback Problem; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE FIRE INITIALLY, BUT AFTER FIVE TO TEN STAPLES THE STAPLER JAMMED AND DID NOT FIRE OUT. ADDITIONALLY, IT WOULD PUT OUT TWO STAPLES AT A TIME EVERY ONCE IN A WHILE. THIS ISSUE OCCURRED WITH A 4 MILLIMETER (MM) AND 4.8 MM STAPLE. TO RESOLVE THE ISSUE, A THIRD STAPLER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21532000 ↗
• MalfunctionOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED URINARY TRACT INFECTION, BLOOD IN THE URINE, PAIN IN THE LOWER ABDOMEN, AND IT WAS NO LONGER POSSIBLE TO HAVE SEXUAL INTERCOURSE.

  Patient problems: Hematuria; Pain; Urinary Tract Infection

  MAUDE report 20566482 ↗
• MalfunctionSep 30, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC HERNIA REPAIR, NO STAPLES WERE ABLE TO BE FIRED NORMALLY FROM THE STAPLER. AT THE FIRST STAPLING, THE DEVICE COULD NOT BE USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20330974 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY, A RETROSPECTIVE STUDY OUTCOME OF THE EVALUATION OF THE SAFETY AND PERFORMANCE OF MEDTRONIC ENDO UNIVERSAL 65 IN ELECTIVE LAPAROSCOPIC INGUINAL, UMBILICAL, EPIGASTRIC AND INCISIONAL HERNIA OPERATIONS (1 YEAR FOLLOW-UP). 1.351 (92.28 %) PATIENTS IN ELECTIVE LAPAROSCOPIC INGUINAL HERNIA REPAIR, 36 (2.46 %) PATIENTS IN ELECTIVE LAPAROSCOPIC UMBILICAL HERNIA REPAIR, 7 (0.48 %) PATIENTS IN ELECTIVE LAPAROSCOPIC EPIGASTRIC HERNIA REPAIR AND 70 (4.78 %) PATIENTS IN ELECTIVE LAPAROSCOPIC INCISIONAL HERNIA REPAIR WERE INCLUDED IN THE STUDY. TISSUE BREAKDOWN (INTRAOPERATIVE ORGAN INJURIES) IS A COMPLICATION. POST OPERATIVE COMPLICATIONS INCLUDED BLEEDING, SEROMA, INFECTION, PAIN AND HERNIA RECURRENCE ARE DEVICE RELATED. ADDITIONAL SURGERY WAS REQUIRED. GENERAL COMPLICATIONS AND COMPLICATION RELATED REOPERATIONS ARE NOT RELATED TO THE DEVICE. HERNIAMED REGISTRY EXTRACTION MEDTRONIC ENDO UNIVERSAL 65 IN ELECTIVE LAPAROSCOPIC INGUINAL, UMBILICAL, EPIGASTRIC AND INCISIONAL HERNIA OPERATIONS (1 YEAR FOLLOW-UP), DR. (B)(6).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hernia; Pain; Seroma; Tissue Breakdown; Unspecified Infection

  MAUDE report 20025919 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY, A RETROSPECTIVE STUDY OUTCOME OF  THE EVALUATION OF THE SAFETY AND PERFORMANCE OF MEDTRONIC ENDO UNIVERSAL 65 IN ELECTIVE LAPAROSCOPIC INGUINAL, UMBILICAL, EPIGASTRIC AND INCISIONAL HERNIA OPERATIONS (1 YEAR FOLLOW-UP). 1.351 (92.28 %) PATIENTS IN ELECTIVE LAPAROSCOPIC INGUINAL HERNIA REPAIR, 36 (2.46 %) PATIENTS IN ELECTIVE LAPAROSCOPIC UMBILICAL HERNIA REPAIR, 7 (0.48 %) PATIENTS IN ELECTIVE LAPAROSCOPIC EPIGASTRIC HERNIA REPAIR AND 70 (4.78 %) PATIENTS IN ELECTIVE LAPAROSCOPIC INCISIONAL HERNIA REPAIR WERE INCLUDED IN THE STUDY. TISSUE BREAKDOWN (INTRAOPERATIVE ORGAN INJURIES) IS A COMPLICATION. POST OPERATIVE COMPLICATIONS INCLUDED BLEEDING, SEROMA, INFECTION, PAIN AND HERNIA RECURRENCE ARE DEVICE RELATED. ADDITIONAL SURGERY WAS REQUIRED. GENERAL COMPLICATIONS AND COMPLICATION RELATED REOPERATIONS ARE NOT RELATED TO THE DEVICE. HERNIAMED REGISTRY EXTRACTION MEDTRONIC ENDO UNIVERSAL 65 IN ELECTIVE LAPAROSCOPIC INGUINAL, UMBILICAL, EPIGASTRIC AND INCISIONAL HERNIA OPERATIONS (1 YEAR FOLLOW-UP), DR. (B)(6).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hernia; Pain; Seroma; Tissue Breakdown; Unspecified Infection

  MAUDE report 20015136 ↗
• MalfunctionAug 14, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE STAPLER WAS LOCKED WHILE ON USE AND COULD NOT FIRE BETWEEN USES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981337 ↗
• MalfunctionJul 23, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC RECTAL PROLAPSE PROMONTO FIXATION, WHEN FIXING THE MESH, THE DEVICE WAS BLOCKED WHEN FIRED. THE CLAMP WOULD NOT FULLY CLOSE, WHICH WOULD SNAG THE STRIP AND THEREFORE WOULD NOT ALLOW STAPLING. THE SURGEON COULD NOT PRESS THE HANDLE AS IT WOULD STAY IN OPEN POSITION. ANOTHER DEVICE WAS USED TO COMPLETE THE FIXATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805385 ↗
• MalfunctionJul 11, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL WALL SCAR HERNIA REPAIR PROCEDURE, THE STAPLES COULD NOT BE FIRED WHEN FIXATING THE MESH. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720826 ↗
• MalfunctionJul 9, 2024Break; Failure to Fire; Break; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TRANSABDOMINAL PRE-PERITONEAL (TAPP) HERNIA PROCEDURE, WHEN PRESSING FOR THE FIRST STAPLE, THERE WERE NO STAPLES ABLE TO FIRE, AND THE HANDLE WAS BROKEN. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705043 ↗
• MalfunctionMar 14, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROLAPSE PROCEDURE, THE WHEN THE SURGEON WAS STAPLING THE PROSTHESIS, THE 1ST STAPLE WAS INSTALLED HOWEVER THE SUBSEQUENT STAPLES DID NOT COME OUT OF THE STAPLER. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 18909656 ↗
• MalfunctionMar 7, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) HERNIA REPAIR PROCEDURE, STAPLES BECAME STUCK IN THE STAPLER, AND THE SURGEON WAS UNABLE TO DEPLOY THE STAPLES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859892 ↗
• MalfunctionFeb 9, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA TAPP (TRANSABDOMINAL PREPERITONEAL) PROCEDURE, AFTER CHANGING THE RELOAD, THE DEVICE GOT STUCK AFTER IT WAS USED. ONLY THE RELOADS THAT CAME WITH THE STAPLER WERE USED CORRECTLY. AFTERWARDS IT NO LONGER CAME OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677451 ↗
• MalfunctionFeb 9, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA TRANSABDOMINAL PREPERITONEAL (TAPP), THE STAPLES GET STUCK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675392 ↗
• MalfunctionJan 19, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA SURGERY, THE STAPLES WERE NOT EXPELLED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545606 ↗
• MalfunctionJan 14, 2024Mechanical Jam; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHEN THE MESH WAS BEING STAPLED TO THE ABDOMINAL WALL, THE FIRST STAPLER JAMMED AND WAS UNABLE TO BE USED. A SECOND STAPLER WAS OPENED, AND IT ALSO JAMMED. THREE STAPLES WERE ABLE TO BE PULLED OUT OF THE CARTRIDGE OF THE FIRST STAPLER, AND THE REMAINING STAPLES IN THE CARTRIDGE WERE USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509704 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K912097. One submission often covers many models, so check the product and lot details in each record.

• Z-2253-2020 · May 12, 2020 · Open, Classified
  Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair
• Z-2252-2020 · May 12, 2020 · Open, Classified
  Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair
• Z-2255-2020 · May 12, 2020 · Open, Classified
  Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of
• Z-2254-2020 · May 12, 2020 · Open, Classified
  Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of