Multifire Endo Hernia 174025Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 10884521070592), received between Aug 22, 2017 and May 28, 2026 — classified as 2 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (28 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Failure to Fire

  ACCORDING TO THE REPORTER DURING A CLOSING OF THE PETERSON'S DEFECT IN BARIATRIC SURGERY, THE HERNIA STAPLER WAS UNABLE TO BE FIRED AND FELT JAMMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25312046 ↗
• MalfunctionJan 22, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING A PROCEDURE, THE STAPLES OF THE HERNIA STAPLER DID NOT DEPLOY. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24153788 ↗
• MalfunctionJan 2, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HERNIA REPAIR, PART OF THE DEVICE BECAME DETACHED AND ENTERED THE PATIENT. THE RELOAD COMPONENT OF THE INSTRUMENT BROKE, AND THE BROKEN PART DISENGAGED, CAUSING PIECES TO FALL INTO THE PATIENT CAVITY. ALL PIECES WERE RETRIEVED AND DISCARDED, AND THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951693 ↗
• MalfunctionJul 22, 2025Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED THAT DURING LAPAROSCOPIC HERNIA REPAIR, DURING CLOSURE OF THE PERITONEUM, THE STAPLER WAS OPENED INTO THE STERILE FIELD AND INSERTED INTO THE ABDOMEN. WHEN THE TRIGGER WAS PULLED, THE FRONT CASING OF THE TRIGGER OPENED, PREVENTING THE STAPLE FROM BEING DEPLOYED. THE STAPLES COULD NOT BE IMPLANTED DUE TO THE BROKEN HANDLE. NO PART OF THE DEVICE FELL INTO THE ABDOMEN. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE, RESULTING IN A DELAY OF NO MORE THAN FIVE MINUTES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569354 ↗
• MalfunctionApr 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A HERNIA REPAIR PROCEDURE, WHEN THE TRIGGER WAS PRESSED, THE BODY OF THE DEVICE OPENED UP. ANOTHER DEVICE HAD TO BE OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21756815 ↗
• MalfunctionMar 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  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 21566858 ↗
• 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 21566003 ↗
• MalfunctionJan 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE TOP OF THE STAPLER WAS CHIPPED OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21116413 ↗
• MalfunctionJan 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER APPROXIMATELY THE FIFTH FIRING OF THE DEVICE, THE END OF THE STAPLER CAME AWAY FROM THE MAIN INSTRUMENT INSIDE THE PATIENT. THE SURGEON IMMEDIATELY REMOVED THE DEVICE FROM THE PATIENT. THE DETACHED END WAS LOCATED AND WAS ALSO REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21076201 ↗
• MalfunctionDec 10, 2024Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE INSTRUMENT BROKE. THE TIP OF THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894437 ↗
• MalfunctionOct 10, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR, WHILE PREPARING TO USE THE STAPLER, THE STAPLES FELL OUT PRIOR TO FIRING. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20419230 ↗
• MalfunctionAug 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BARIATRIC PROCEDURE, AFTER 10 STAPLES, WHILE TRYING TO FIRE ANOTHER STAPLE, THE RELOAD GOT DISCONNECTED FROM THE HANDLE WHILE IN THE PATIENT. TO RESOLVE THE ISSUE, THE RELOAD WAS REMOVED WITH A GRASPER VIA TROCAR, AND THE HANDLE WAS ALSO REMOVED AS THE PROCEDURE WAS FINISHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982606 ↗
• MalfunctionAug 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE DOCTOR WENT TO FIRE THE STAPLER INSIDE THE PATIENT, THE TIP FLEW OFF. THE USER WAS ABLE TO RETRIEVE THE SAME RELOAD AND TRIED TO RELOAD IT OUTSIDE OF THE PATIENT AND PERFORM A TEST FIRE AND THE SAME THING HAPPENED. A NEW PRODUCT WAS OPENED AND USED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978233 ↗
• MalfunctionJun 28, 2024Break; Failure to Fire; Detachment of Device or Device Component; Mechanical Jam; Break; Failure to Fire; Detachment of Device or Device Component; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HERNIA REPAIR, THE HANDLE PHYSICALLY BROKE DURING FIRING. THE STAPLER DID NOT FIRE. A NEW DEVICE WAS USED TO FINISH THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19635349 ↗
• MalfunctionJun 12, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC BYPASS PROCEDURE,  THE GUN FAILED TO DELIVER STAPLES. THE GUN WAS THEN CHANGED AND WORKED PERFECTLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519099 ↗
• MalfunctionMar 4, 2024Failure to Form Staple; Mechanics Altered; Failure to Form Staple; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BARIATRIC SURGERY (GASTRIC BYPASS), THE LAST STEP OF THE PROCEDURE, THE STAPLE DID NOT COME OUT OF THE DEVICE AS THEY NORMALLY DO, CAME OUT "CROOKED" INSTEAD OF STRAIGHT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18828326 ↗
• MalfunctionFeb 21, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS, A LAST STEP TO CLOSE THE MESENTERY, THE STAPLER WOULD NOT CLOSE PROPERLY, AND ON THE SECOND DEVICE, THE SURGEON SQUEEZE THE HANDLE IT BROKE, IT WAS STILL IN PLACE BUT WITH NO RESISTANCE. A THIRD DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18750573 ↗
• MalfunctionFeb 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING INGUINAL HERNIA PROCEDURE, THE END OF THE STAPLER BROKE OFF AFTER THE INSTALLATION OF STAPLES. NO DEVICE COMPONENT FELL INTO THE PATIENT'S CAVITY. A NEW STAPLER FROM THE SAME COMPANY WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 18654512 ↗
• MalfunctionFeb 2, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, WHEN CLOSING THE SLITS, THE SURGEON WAS ABLE TO FIRE ONE CLIP. WHEN TRYING TO FIRE CLIP NUMBER TWO, THE INSTRUMENT JAMMED AND LOCKED ITSELF, MAKING IT IMPOSSIBLE TO FIRE AGAIN. ANOTHER HERNIA STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631698 ↗
• MalfunctionFeb 2, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS (LGBP) PROCEDURE, WHILE CHANGING THE RELOAD, THE RELOAD BROKE IN THE TOP OF THE INSTRUMENT. A NEW RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18630661 ↗
• MalfunctionJan 30, 2024Device Slipped; Failure to Fire; Device Slipped; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC GASTRIC BYPASS, DURING THE LAST STEP, CLOSING THE MESENTERY, THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE. THE PLASTIC ON THE TIP WAS LOOSE. THE DEVICE COULD NOT BE FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607923 ↗
• MalfunctionJan 29, 2024Failure to Form Staple; Difficult to Open or Close; Failure to Form Staple; Difficult to Open or Close

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRIC BYPASS, WHILE IN THE MESENTERY FOR THE LAST STEP, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, BUT THE STAPLES DID NOT CLOSE DURING FIRING. THE JAWS WERE UNABLE TO CLOSE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18601421 ↗
• MalfunctionJan 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GASTRIC BYPASS, THE STAPLER BROKE OFF AT THE FRONT, WHICH WAS THE MAGAZINE. IT WAS NOTED THAT IT WAS NOT INSIDE THE PATIENT. IT HAD BEEN SOLVED LAPAROSCOPICALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522514 ↗
• MalfunctionJan 4, 2024Break; Break

  ACCORDING TO THE REPORTER, THE INSTRUMENT WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 18446639 ↗
• MalfunctionJan 4, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TACKER MISFIRED AFTER RELOAD.

  Patient problems: Insufficient Information

  MAUDE report 18446568 ↗

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-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-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-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