Multifire VersaTack 174023Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10884521070578), received between Jun 19, 2017 and May 27, 2026 — classified as 64 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 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 25298828 ↗
• MalfunctionFeb 24, 2025Product Quality Problem; Failure to Fire; Product Quality Problem; Failure to Fire

  ACCORDING TO THE REPORTER, IN AN OPEN HERNIA REPAIR, NO TACKS WERE ABLE TO BE FIRED NORMALLY FROM THE DEVICE. THERE WAS A NOTICEABLE GAP BETWEEN THE TWO PARTS OF THE TIP OF THE TACKER. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447463 ↗
• MalfunctionJul 25, 2024Break; Failure to Fire; Break; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLES WERE NOT ABLE TO BE FIRED FROM THE DEVICE. ADDITIONALLY, THE HANDLE BROKE. TO RESOLVE THE ISSUE, ANOTHER STAPLER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19830769 ↗
• 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 18402192 ↗
• 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 16797970 ↗
• MalfunctionApr 19, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN HERNIA SURGERY, WHEN HOLDING THE CLAMP, THE CLAMP DISENGAGED. ANOTHER TACKER WAS 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 16771400 ↗
• MalfunctionOct 18, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, WHEN TRYING TO RELOAD THE STAPLER, THE PIECE AT END WAS BROKE. OPENED A NEW DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621162 ↗
• MalfunctionSep 7, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374792 ↗
• MalfunctionSep 7, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374768 ↗
• MalfunctionSep 7, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374707 ↗
• MalfunctionSep 7, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374648 ↗
• MalfunctionSep 7, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374635 ↗
• MalfunctionSep 7, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374616 ↗
• MalfunctionSep 7, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374611 ↗
• MalfunctionSep 7, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374601 ↗
• MalfunctionSep 7, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374529 ↗
• MalfunctionSep 7, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374505 ↗
• MalfunctionSep 7, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374465 ↗
• MalfunctionSep 7, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374432 ↗
• MalfunctionSep 7, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15374417 ↗
• MalfunctionSep 6, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL PROCEDURE, THE UNIT JAMMED. THE SURGEON TRIED PUTTING IN A REPLACEMENT RELOAD CARTRIDGE BUT THAT DID NOT WORK. THE COMPLETE UNIT WOULD NOT FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363882 ↗
• MalfunctionJun 15, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, NO TACKS WERE FIRED NORMALLY FROM THE DEVICE. ANOTHER NEW DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14703165 ↗
• MalfunctionMay 3, 2022Loss of or Failure to Bond; Failure to Form Staple; Loss of or Failure to Bond; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, WHILE FIXING A POLYPROPYLENE MESH TO THE PATIENT'S WALL, THE STAPLE CAME OUT CROOKED AND DID NOT CATCH THE TISSUE OF THE WALL. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269375 ↗
• MalfunctionSep 30, 2021Positioning Failure; Failure to Fire; Positioning Failure; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, NO TACKS WERE ABLE TO BE FIRED FROM THE DEVICE.

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

  MAUDE report 12557408 ↗
• MalfunctionMar 31, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE FIXATION OF THE MESH TO THE FASCIA ON AN OPEN HERNIA REPAIR, THE LEVER WAS SQUEEZED AND STAPLES WERE DEPLOYED. HOWEVER, STAPLES WERE NOT FORMED PROPERLY. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595209 ↗

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-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