Multifire Endo Hernia 174027Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 10884521070608), received between Aug 23, 2017 and Apr 21, 2026 — classified as 2 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (35 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 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HERNIA REPAIR PROCEDURE, THE TIP OF THE DEVICE BROKE OFF IN THE PATIENT WHEN FIRED. THE BROKEN PIECE WAS RETRIEVED. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES.

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

  MAUDE report 24935185 ↗
• MalfunctionFeb 19, 2026Component or Accessory Incompatibility; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER FIRED WITHOUT ISSUE WITH THE PRE-LOADED STAPLES, BUT WHEN THE SECOND RELOAD WAS INSERTED, THE STAPLER FAILED TO CORRECTLY SEAT THE STAPLES. THE STAPLES FELL OUT PRIOR TO FIRING. A NEW RELOAD WAS USED, BUT THE SAME ISSUE OCCURRED WITH ONE SIDE CLOSING CORRECTLY AND THE OTHER FAILING. THE RELOADS WERE TESTED ON ANOTHER STAPLER WHICH WAS OPENED AND THE RELOADS FUNCTIONED CORRECTLY. THE RELOADS WERE THEN CHECKED ON THE ORIGINAL STAPLER AND STILL FAILED TO OPERATE AS IT SHOULD. THE ISSUE RESULTED IN LESS THAN 5 MINUTES OF PROLONGED SURGICAL TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385852 ↗
• MalfunctionJul 24, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC PROMONTO-FIXATION PROCEDURE, WHEN THE SURGEON NEEDED TO FIX THE MESH, THE TWO HERNIA STAPLERS WERE UNABLE TO FIRE. THE STAPLES WERE BLOCKED INSIDE THE RELOAD AND THE RELOAD DID NOT FUNCTION AS USUAL WHEN THE SURGEON PRESSED THE HANDLE TO FIRE THE STAPLERS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22598322 ↗
• MalfunctionJul 24, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC PROMONTO-FIXATION PROCEDURE, WHEN THE SURGEON NEEDED TO FIX THE MESH, THE TWO HERNIA ST APLERS WERE UNABLE TO FIRE. THE STAPLES WERE BLOCKED INSIDE THE RELOAD AND THE RELOAD DID NOT FUNCTION AS USUAL WHEN THE SURGEON PRESSED THE HANDLE TO FIRE THE STAPLERS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22597211 ↗
• MalfunctionMar 20, 2025Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, TACKS WERE UNABLE TO BE FIRED NORMALLY FROM THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655287 ↗
• MalfunctionMar 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT NO STAPLES WERE ABLE TO BE FIRED NORMALLY FROM THE TWO DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596998 ↗
• MalfunctionMar 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT NO STAPLES WERE ABLE TO BE FIRED NORMALLY FROM THE TWO DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596993 ↗
• MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC PROCEDURE, THE PLIERS BROKE DURING USE. AT THE LEVEL OF THE STAPLES, EVERYTHING CAME OFF THE PLIERS. THE STAPLE CHARGER FELL INTO THE PATIENT¿S CAVITY. THE STAPLE CHARGER WAS TAKEN OUT AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21291576 ↗
• MalfunctionJan 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY THE CARTRIDGE AUTOMATICALLY CAME OFF THE DEVICE WHEN TRYING TO FIRE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093411 ↗
• MalfunctionSep 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN INGUINAL HERNIA REPAIR, THE STAPLER CARTRIDGE KEEPS FALLING OFF EVEN WITHOUT FIRING. TO RESOLVE THE ISSUE, A NEW HANDLE AND RELOAD WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170854 ↗
• MalfunctionAug 14, 2024Display or Visual Feedback Problem; Detachment of Device or Device Component; Display or Visual Feedback Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE STAPLE NAILS FELL OFF AUTOMATICALLY BEFORE FIRING COMPLETELY. THE ISSUE PERSISTED AFTER CHANGING THE RELOAD.

  Patient problems: Insufficient Information

  MAUDE report 19982998 ↗
• MalfunctionJul 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) HERNIA PROCEDURE, THE PRELOADED RELOAD WAS ABLE TO FIRE PROPERLY. THE RELOAD WAS REPLACED TO A NEW ONE, BUT THE RELOAD FELL INTO THE ABDOMEN. A NEW RELOAD WAS REPLACED AGAIN, AND IT FELL AGAIN INTO THE ABDOMEN. IT WAS NOTED THAT THE TWO RELOADS WERE ABLE TO RETRIEVE BY SURGICAL TECHNIQUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706132 ↗
• MalfunctionJul 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) HERNIA PROCEDURE, THE PRELOADED RELOAD WAS ABLE TO FIRE PROPERLY. THE RELOAD WAS REPLACED TO A NEW ONE, BUT THE RELOAD FELL INTO THE ABDOMEN. A NEW RELOAD WAS REPLACED AGAIN, AND IT FELL AGAIN INTO THE ABDOMEN. IT WAS NOTED THAT THE TWO RELOADS WERE ABLE TO RETRIEVE BY SURGICAL TECHNIQUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706105 ↗
• MalfunctionJul 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) HERNIA PROCEDURE, THE PRELOADED RELOAD WAS ABLE TO FIRE PROPERLY. THE RELOAD WAS REPLACED TO A NEW ONE, BUT THE RELOAD FELL INTO THE ABDOMEN. A NEW RELOAD WAS REPLACED AGAIN, AND IT FELL AGAIN INTO THE ABDOMEN. IT WAS NOTED THAT THE TWO RELOADS WERE ABLE TO RETRIEVE BY SURGICAL TECHNIQUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19704980 ↗
• MalfunctionJul 4, 2024Detachment of Device or Device Component; Mechanics Altered; Detachment of Device or Device Component; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) HERNIA REPAIR PROCEDURE, THE SURGEON WAS ABLE TO FIRE THE FIRST RELOAD THAT CAME WITH THE STAPLER. AFTER CHANGING THE RELOAD, IT FELL INTO THE PATIENT'S ABDOMEN. THE SURGEON WAS ABLE TO RETRIEVE IT. THEY LOADED A THIRD RELOAD, WHICH ALSO FELL INTO THE ABDOMEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19675180 ↗
• MalfunctionJun 3, 2024Break; Failure to Fire; Break; Failure to Fire

  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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19445169 ↗
• MalfunctionMar 29, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN AN ATTEMPT WAS MADE FOR FIRING, THE DEVICE DID NOT FIRE. THE STAPLER WAS IN DIAGONAL STATE, SO THE FIRING COULD NOT BE DONE PROPERLY. THE CARTRIDGE WAS REPLACED, BUT THE SAME ISSUE OCCURRED. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006098 ↗
• MalfunctionMar 12, 2024Device Difficult to Setup or Prepare; Failure to Fire; Device Difficult to Setup or Prepare; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ESOPHAGEAL HIATUS HERNIA REPAIR, DURING FIXATION OF THE MESH, THE DEVICE DID NOT PROPERLY FIRE. THE RELOAD WAS TAPED AROUND THE HANDLE AND TUCKED IT TO BE FIRED PROPERLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891825 ↗
• MalfunctionFeb 27, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE DID NOT CLOSE THE STAPLES WELL. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18794099 ↗
• MalfunctionDec 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN AN OPEN HERNIA REPAIR, THE CARTRIDGE CAME OFF DURING THE SECOND TO THE THIRD FIRING OF THE STAPLER. 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 18380311 ↗
• MalfunctionDec 12, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROLAPSE PROCEDURE, THE END OF THE PLIERS OF THE FIRST DEVICE STAYED IN THE PATIENT. THEN, FINALLY IT WAS OKAY. AFTER THE HANDLE OF THE SECOND AND THIRD DEVICES WERE SQUEEZED, THE DEVICES DID NOT FIRE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18312057 ↗
• MalfunctionDec 1, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROLAPSE PROCEDURE, THE END OF THE PLIERS OF THE FIRST DEVICE STAYED IN THE PATIENT. THEN, FINALLY IT WAS OKAY. AFTER THE HANDLE OF THE SECOND AND THIRD DEVICES WERE SQUEEZED, THE DEVICES DID NOT FIRE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18247290 ↗
• MalfunctionNov 20, 2023Failure to Form Staple; Failure to Fire; Mechanics Altered; Failure to Form Staple; Failure to Fire; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROLAPSE, AT THE BEGINNING, THE DEVICE DID NOT FIRE. WHEN THE DEVICE FIRED, THE STAPLE DID NOT FORM PROPERLY. ADDITIONALLY, AFTER SEVERAL FIRINGS, THE STAPLE AGGLOMERATE. TO RESOLVE THE ISSUE, ANOTHER DEVICE WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 18171591 ↗
• MalfunctionNov 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ANTERIOR PROMONTOFIXATION, WHEN USING THE STAPLER, THE PRE-ASSEMBLED STAPLE RELOAD WAS EXTRACTED AND FELL INTO THE ABDOMEN. THE EVENT REPEATED WITH A SECOND STAPLER FROM THE SAME BATCH. THE STAPLES WERE EXTRACTED FROM THE ABDOMEN USING LAPAROSCOPIC FORCEPS BY THE SURGEON. THE INTERVENTION DURATION WAS EXTENDED BY 10 MINUTES AS A RESULT. TO COMPLETE THE CASE, ANOTHER DEVICE FROM A DIFFERENT LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096798 ↗
• MalfunctionNov 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ANTERIOR PROMONTOFIXATION, WHEN USING THE STAPLER, THE PRE-ASSEMBLED STAPLE RELOAD WAS EXTRACTED AND FELL INTO THE ABDOMEN. THE EVENT REPEATED WITH A SECOND STAPLER FROM THE SAME BATCH. THE STAPLES WERE EXTRACTED FROM THE ABDOMEN USING LAPAROSCOPIC FORCEPS BY THE SURGEON. THE INTERVENTION DURATION WAS EXTENDED BY 10 MINUTES AS A RESULT. TO COMPLETE THE CASE ANOTHER DEVICE FROM A DIFFERENT LOT NUMBER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096759 ↗

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-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-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-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