Multifire VersaTack 174021Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10884521070561), received between Aug 23, 2017 and Apr 9, 2024 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (9 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE WAS DEFECTIVE AT THE TIME OF STAPLING; CLAMPING WAS FAULTY DURING GRAFT. THE TIP BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. IT WAS REPORTED THAT THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19074025 ↗
• MalfunctionJan 20, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING OPEN SURGERY FOR DIRECT ACCESS INGUINAL HERNIA, THE STAPLES DID NOT CLOSE PROPERLY ON THE MESH. NO COMPONENT FELL INTO PATIENT CAVITY. THE MESH WAS FIXED WITH A SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214008 ↗
• MalfunctionSep 24, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A CELIO PROCEDURE BEFORE USING THE DEVICE ON THE PATIENT, THE DEVICE PHYSICALLY BROKE AND DID NOT WORK AS SOON AS IT WAS ACTIVATED. NO TACKS WERE ABLE TO BE FIRED FROM THE DEVICE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 15479441 ↗
• MalfunctionSep 14, 2022Break; Failure to Fire; Break; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE CLEAR END TIP OF THE TWO STAPLERS WERE BROKEN, BOTH DEVICES WERE NOT ABLE TO FIRE NORMALLY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 15421675 ↗
• MalfunctionSep 14, 2022Break; Failure to Fire; Break; Failure to Fire

  ACCORDING TO THE REPORTER, THE CLEAR END TIP OF THE 2 STAPLERS WERE BROKEN DURING THEIR USE.

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

  MAUDE report 15421535 ↗
• MalfunctionAug 5, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE WOULD NOT FUNCTION. THE DEVICE WORKS IN A VACUUM AND STAPLING COULD NOT BE PERFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15179994 ↗
• MalfunctionMar 23, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PRIMARY REPAIR OF INGUINAL HERNIA, THE DEVICE KEPT ON JAMMING.  NO TACKS WERE ABLE TO BE FIRED NORMALLY FROM THE DEVICE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870058 ↗
• MalfunctionMar 23, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING AN INGUINAL HERNIA PROCEDURE, THE ROD INSTRUMENT BROKE AND SEPARATED INTO THREE PIECES. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869534 ↗
• MalfunctionApr 12, 2021Break; Mechanics Altered; Material Split, Cut or Torn; Break; Mechanics Altered; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A HERNIA EVENTRATION PROCEDURE, THE DEVICE HAS BEEN BROKEN IN THE SURGEON'S HANDS, IT OPENED IN TWO LENGTHWISE. IN ADDITION THERE WERE DIFFICULTIES WITH LOADING THE RELOAD ONTO THE HANDLE AND DIFFICULTY WITH NAVIGATING THE LOCK AND UNLOCK BUTTON. THE SURGEON THEN USED ANOTHER DEVICE 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 11654092 ↗
• MalfunctionDec 23, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, WHILE FIXATING THE MESH IN AN OPEN HERNIA REPAIR, NO TACKS WERE ABLE TO BE FIRED NORMALLY FROM THE DEVICE. TACKS WOULD STUCK ON THE MESH, MAKING IT DIFFICULT TO APPLY TACKS AND RISKING TO TEAR THE MESH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11067080 ↗
• MalfunctionJul 23, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING PROMONTOFIXATION BY LAPAROTOMY PROCEDURE, THE SURGEON USED A FIRST CLAMP THAT WORKED PERFECTLY, AND ASKED FOR A SECOND TO FINISH FIXING HIS PLATE. HOWEVER THIS SECOND CLAMP DID NOT DELIVER A STAPLE, THE DEVICE WAS BLOCKED AND NO STAPLE CAME OUT OR WOULD NOT DELIVER A CLIP WHEN THE SURGEON ACTUATED IT. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10316511 ↗
• MalfunctionFeb 7, 2020Mechanical Jam; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE JAMMED UPON FIRING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9684062 ↗
• MalfunctionDec 20, 2019Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE WAS BROKEN. IT WAS STATED THAT THERE WAS NO DAMAGES OUTSIDE THE BOX.

  Patient problems: No Information

  MAUDE report 9507005 ↗
• MalfunctionOct 1, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE STAPLES CAME OUT AT AN ANGLE. IT WAS REPORTED THAT THE RELOAD WAS DIFFICULT TO LOAD ONTO THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9143399 ↗
• MalfunctionJul 22, 2019Loss of or Failure to Bond; Display or Visual Feedback Problem; Loss of or Failure to Bond; Display or Visual Feedback Problem

  ACCORDING TO THE REPORTER, DURING FIXATION OF MESH ON A LICHTENSTEIN HERNIA REPAIR, THE DEVICE FIRED TWO TACKS ON THE SAME TIME RATHER THAT JUST ONE. IN ADDITION, A FIRED TACKS DID NOT HOLD CORRECTLY ONTO THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811790 ↗
• MalfunctionJun 17, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY ON A BILATERAL INGUINAL HERNIA REPAIR PROCEDURE, THE DEVICE COULD NOT FIRE AND ZERO STAPLES CAME OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8706011 ↗
• MalfunctionJan 10, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN INGUINAL HERNIA REPAIR, THE STAPLE WOULD NOT CLOSE. OPENED A NEW DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8237585 ↗
• MalfunctionDec 4, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TREATMENT FOR HERNIA REPAIR, THE EQUIPMENT MISFIRED STAPLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8130236 ↗
• MalfunctionJul 31, 2018Break; Material Fragmentation; Packaging Problem; Break; Packaging Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS IN SMALL PIECES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7734753 ↗
• MalfunctionJul 3, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THE DEVICE HAD A MALFUNCTION, THERE WAS A GRIP PROBLEM, IT DID NOT MAKE IT POSSIBLE TO STAPLE THE PROSTHESIS TO THE TISSUES, IT DID NOT DEPLOY AND THE DEVICE DID NOT FIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7658872 ↗
• MalfunctionJun 26, 2018Shelf Life Exceeded; Shelf Life Exceeded

  ACCORDING TO THE REPORTER, DURING A VENTRAL INTRAPERITONEAL MESH PLACEMENT, THE PRODUCT HAD EXCEEDED THE EXPIRY DATE WHEN THE SURGEON USED THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7637687 ↗
• MalfunctionJun 11, 2018Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING AN INGUINAL HERNIA PROCEDURE, WHILE BEING APPLIED FOR THE MESH FIXATION, THE DEVICE PARTIALLY FIRED. ANOTHER DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7589142 ↗
• MalfunctionMar 23, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE WAS NOT FIRING PROPERLY. NO REPORTED PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7365736 ↗
• MalfunctionMar 22, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING AN OPEN INGUINAL HERNIA PROCEDURE, WHILE FIXATING THE MESH, THE DEVICE ONLY PARTIALLY FIRED. EVEN AFTER RECHARGE CHANGED IT WAS IMPOSSIBLE TO FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7363845 ↗
• MalfunctionOct 27, 2017Failure to Fire; Mechanics Altered; Failure to Fire; Mechanics Altered

  ACCORDING THE REPORTER, ON (B)(6) 2017, DURING AN OPEN INGUINAL HERNIA SURGERY, THE STAPLER DID NOT FIRE AND THE STAPLES DID NOT DEPLOY WHEN THE SURGEON NEED TO FIX THE MESH AT THE END OF THE SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY NOTED DURING THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6983170 ↗

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-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