Multifire Endo Hernia 174007Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10884521070547), received between Aug 22, 2017 and May 27, 2026 — classified as 4 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD A HEMATOMA IN THE RIGHT TESTICLE AND SIGNIFICANT PAIN IN THE ON THE SAME SIDE. THE PATIENT WAS OPERATED ON (B)(6) 2024, AND SINCE THEN, THE PATIENT WAS EXPERIENCING STABBING SENSATIONS AND PAIN WHILE WALKING WHICH WERE VERY DISABLING.

  Patient problems: Hematoma; Pain

  MAUDE report 25298813 ↗
• InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POSTOPERATIVELY OF A BILATERAL TRANSABDOMINAL PREPERITONEAL (TAPP) INGUINAL HERNIA LAPAROSCOPIC PROCEDURE, AN ADHESION OF THE CLIP TO THE BOWEL OCCURRED AFTER THE PROCEDURE. MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO REMOVE THE ADHESION TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE ADHERENCE OF THE CLIP TO THE BOWEL WAS RESOLVED BY REMOVING THE ADHESION. THE PATIENT WAS RE-OPERATED IN ANOTHER HOSPITAL. THE SURGEON REMOVED THE STAPLES THAT HAD COME UNDONE.

  Patient problems: Adhesion(s)

  MAUDE report 21602779 ↗
• MalfunctionMar 10, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE, THE FIRST STAPLER WAS FIRING BUT THE STAPLES WERE NOT CLOSING FULLY. A STAPLE RELOAD WAS USED TO DETERMINE WHETHER THE PROBLEM WAS WITH THE CARTRIDGE OR THE GUN BUT THE STAPLES WOULD NOT CLOSE FULLY SO A SECOND GUN WAS OPENED. WHEN THE DEVICE WAS INSERTED INTO THE PATIENT AND THE HANDLE PRESSED, THE STAPLE CARTRIDGE EJECTED INTO THE CAVITY AND HAD TO BE RETRIEVED. THE SURGEON TRIED IT A FEW TIMES OUTSIDE THE CAVITY AGAIN AND THE SAME THING HAPPENED. A THIRD STAPLER WAS USED TO RESOLVE THE ISSUE. THE PATIENT WAS KEPT LONGER UNDER ANESTHETICS FOR ABOUT FIFTEEN MINUTES LONGER WHILE THIS WAS BEING SORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21562473 ↗
• MalfunctionApr 22, 2024Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem; Component or Accessory Incompatibility; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL, THE RELOADS WERE HARD TO LOAD AND UNLOAD. AFTER THREE R ELOADS, THE PLASTIC COMPONENT DETACHED AND FELL INTO THE CAVITY OF THE PATIENT BUT IT WAS NOTED THAT THE COMPONENT WAS RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152780 ↗
• MalfunctionMar 7, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) HERNIA REPAIR PROCEDURE, THE 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 18858308 ↗
• MalfunctionMar 5, 2024Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

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

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

  MAUDE report 18837316 ↗
• MalfunctionDec 27, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LEFT INGUINAL HERNIA REPAIR WITH MESH, WHEN DEPRESSING THE TRIGGER, THE STAPLE WOULD RELEASE BUT THE STAPLES DID NOT CLOSED FULLY. ATTEMPTED TO USE WITH A NEW LOAD BUT SAME ISSUE OCCURRED. A NEW HERNIA STAPLER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 18402166 ↗
• MalfunctionApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, A PLASTIC TAB AT THE END OF THE CLAMP HAD DISLODGED IN INTRA-ABDOMINAL AND WAS NO LONGER FUNCTIONAL. NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16798175 ↗
• MalfunctionApr 20, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, CLOSING OF THE MESENTERY, THE STAPLES DID NOT FIRE, THE USER CHANGED TO A NEW RELOAD; STILL THERE WAS NO STAPLES COMING OUT. IT WAS NOTED THAT THE HANDLE WAS ABLE TO SQUEEZED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16781246 ↗
• MalfunctionJan 20, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, WHEN THE DEVICE WAS LOADED WITH 4.8MM, THE SURGEON APPLIED PRESSURE TO CLOSE THE PERITONEUM AND THE STAPLE WOULD NOT DEPLOY. THE SURGEON TRIED TO PULL THE DEVICE OUT AND FIRE THE DEVICE, BUT THE STAPLE WOULD NOT DEPLOY; IT WAS JAMMED. ANOTHER DEVICE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214068 ↗
• InjuryOct 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE FOR OBESITY, AFTER RELOADING THE INSTRUMENT, WHILE ON CLOSURE OF OMENTUM, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND A PART OF RELOAD DISENGAGED INTO THE CAVITY OF THE PATIENT. THE BROKEN PARTS THAT FELL INTO THE PATIENT'S CAVITY WERE RETRIEVED WITH A HAND INSTRUMENT. THE SURGEON COMPARED THE DEVICE THOROUGHLY TO A NON-BROKEN DEVICE TO MAKE SURE NOTHING WAS MISSING AND THE OMENTUM WAS CLOSED WITH SUTURE. THE PATIENT IS CURRENTLY FINE.

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

  MAUDE report 15667672 ↗
• MalfunctionOct 5, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TRANSABDOMINAL PRE-PERITONEAL SURGERY, AT FIXATION OF THE MESH , THE STAPLES THAT CAME WITH THE HANDLE WOULD NOT CLOSE. A NEW LOADING UNIT WAS USED BUT HAD THE SAME ISSUE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544382 ↗
• MalfunctionJun 27, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING TRANSABDOMINAL PREPERITONEAL (TAPP) HERNIA PROCEDURE, AT THE 2ND CARTRIDGE, THE STAPLES COME OUT OF ALIGNMENT FOR BOTH DEVICES REPORTED AS THEY WORKS ALONGSIDE WITH EACH OTHER. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14836982 ↗
• MalfunctionJun 3, 2022Failure to Fire; Noise, Audible; Failure to Fire; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA TRANSABDOMINAL PREPERITONEAL (TAPP) PROCEDURE, THE TWO STAPLERS NO LONGER DELIVERED THE LAST STAPLES AND MADE AN UNUSUAL NOISE ON THE THIRD CARTRIDGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14593548 ↗
• MalfunctionJun 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL HERNIA PROCEDURE, THE TWO DEVICES WERE USED. A PLASTIC TIP FELL OFF INTO THE PATIENT'S ABDOMEN AND WAS RETRIEVED USING A LAPAROSCOPIC INSTRUMENT. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14593523 ↗
• MalfunctionNov 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING THE HERNIA SURGERY VIA LAPAROSCOPIC, THE DEVICE COMPONENT DISENGAGED INTO THE CAVITY. THE SURGEON WAS NOT SURE WHAT PLASTIC PART CAME FROM EITHER THE CARTRIDGE OR INSTRUMENT. TO RESOLVE THE ISSUE THE SURGEON FIND AND RETRIEVED THE PIECE THAT FELT IN THE ABDOMEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868856 ↗
• MalfunctionJun 9, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVE A HERNIA PROCEDURE, THE STAPLER DID NOT FIRE. IT WAS ALSO NOTED THAT SOME CLEAR PLASTIC FELL INTO THE PATIENT'S CAVITY BUT WAS RETRIEVED WITH A GRASPER. THE SECOND DEVICE BROKE AND A PIECE FELL INTO THE CAVITY AND WAS ALSO RETRIEVED. SURGEON USED ANOTHER STAPLER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968677 ↗
• MalfunctionJun 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA REPAIR, THE LOADING UNIT FELL OFF INTO PATIENT'S CAVITY WHEN THE DEVICE WAS INSERTED. THE RELOAD HAD BEEN RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941100 ↗
• MalfunctionMay 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING MESH FIXATION IN A HERNIA REPAIR, 3 RELOADS HAVE FELL INTO THE CAVITY WHEN TRIED TO BE FIRED. THEY HAVE BEEN RETRIEVED WITH AN INSTRUMENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11790809 ↗
• MalfunctionFeb 16, 2021Break; Failure to Form Staple; Break; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BILATERAL HERNIA REPAIR, WHILE CLOSING THE PERITONEUM, TWO STAPLERS WERE USED. WHEN THE FIRST DEVICE WAS USED, THE PLASTIC TIP CAME OFF OF THE DISTAL END OF THE DEVICE INTO THE PATIENT. THE SURGEON RETRIEVED THE PLASTIC TIP USING A GRASPER AND ANOTHER STAPLER WAS OPENED. WHEN THE SECOND STAPLER WAS USED, THE STAPLES MALFORMED AND THE HANDLE ALSO BROKE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11332879 ↗
• MalfunctionDec 21, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING AN OPEN EVENTRATION CURE, WHEN STAPLING THE MESH, THE STAPLES DID NOT HOLD ONTO THE MESH AND REMAINED STUCK IN THE CARTRIDGE. THE CHARGER HAS BEEN CHANGED AND THE SAME PROBLEM WAS ENCOUNTERED WITH THE STAPLER. A NEW DEVICE WITH THE SAME LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11047229 ↗
• MalfunctionApr 14, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ACCORDING TO THE REPORTER, DURING CLOSURE OF MESENTERIC DEFECT ON A LAPAROSCOPIC GASTRIC BYPASS, WHENEVER THE DEVICE WAS BEING FIRED, TWO STAPLES WERE FIRED INSTEAD OF ONE. RELOADING THE DEVICE WAS IMPOSSIBLE AS THE WHOLE UNIT OF THE DEVICE CAME OFF RATHER THAN JUST THE RELOAD PART. THREE OTHER HANDLES AND TWO OTHER RELOADS WERE USED BUT SAME ISSUE OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9960905 ↗
• MalfunctionApr 14, 2020Display or Visual Feedback Problem; Failure to Form Staple; Display or Visual Feedback Problem; Failure to Form Staple

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS USED TO CLOSE THE MESENTERIC DEFECT DURING A LAPAROSCOPIC GASTRIC BYPASS, THE STAPLE CAME OUT WITHOUT CORRECTLY FOLDING AND THE TWO STAPLES WERE FIRED AT THE SAME TIME CAUSING IT TO JAM. A RELOAD WAS ALSO FIRED AND THIS PROBLEM OCCLUDED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9960904 ↗
• MalfunctionApr 6, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING RIGHT INGUINAL HERNIA, WHILE CLOSING PERITONEUM, STAPLES COULD NOT FIRE FROM STAPLER. IT WAS AS IF THEY JAMMED AT EXIT FROM STAPLER. SURGEON ATTEMPTED TO REMOVE THE CLUSTER OF STAPLES TO CLEAR IT BUT WAS UNABLE TO UNTANGLE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9931764 ↗
• MalfunctionMar 23, 2020Loss of or Failure to Bond; Failure to Form Staple; Loss of or Failure to Bond; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, THE DEVICES WERE ABLE TO FIRE, BUT STAPLES DID NOT CLOSE COMPLETELY AND HOLD ON TISSUE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9869596 ↗

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-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-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-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
• 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