Multifire Endo Hernia 174015Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10884521070554), received between Sep 20, 2017 and Feb 19, 2026 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (7 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• 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 24385853 ↗
• 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 PROLONGED SURGICAL TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385802 ↗
• MalfunctionOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED URINARY TRACT INFECTION, BLOOD IN THE URINE, PAIN IN THE LOWER ABDOMEN, AND IT WAS NO LONGER POSSIBLE TO HAVE SEXUAL INTERCOURSE.

  Patient problems: Hematuria; Pain; Urinary Tract Infection

  MAUDE report 20566323 ↗
• MalfunctionMay 24, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE STAPLES CAME OUT CLOSED AND UNABLE TO STAPLE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: Tissue Breakdown

  MAUDE report 19397940 ↗
• 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 19006019 ↗
• MalfunctionMar 27, 2024Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, AT THE TIME OF STAPLING IN THE MESH, THE DEVICE DID NOT DEPLOY PROPERLY; THE STAPLE GOT STUCK HALF WAY IN THE DEVICE AND HALF WAY OUT OF THE DEVICE. AN ADDITIONAL 4.0 RELOAD WAS THEN USED, BUT IT DID NOT DEPLOY CORRECTLY TOO. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988433 ↗
• 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 TWO DEVICES DID NOT PROPERLY FIRE FROM THE DEVICE. THE CARTRIDGE WAS ANCHORED WITH TAPE AND WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891828 ↗
• MalfunctionSep 21, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROMONTOFIXATION, AT THE TIME OF MESH FIXATION, THE HANDLE REMAINED BLOCKED. THE SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789440 ↗
• MalfunctionMar 28, 2023Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHEN THE SURGEON WAS TRYING TO TACK THE MESH TO THE PATIENT'S ABDOMINAL WALL, FIRST RELOAD FIRED A FEW STAPLES THEN JAMMED. A NEW RELOAD WAS PUT INTO THE STAPLER AND IT JAMMED RIGHT AWAY (NO STAPLES FIRED). SECOND RELOAD WAS USED IN THE NEW STAPLER THAT WAS OPENED TO COMPLETE THE CASE AND WORKED SUFFICIENTLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16629332 ↗
• MalfunctionMar 23, 2023Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLES DID NOT COME OUT OF THE LOADING UNIT THAT CAME OFF AND FELL INTO THE PATIENT¿S CAVITY. THE LOADING UNIT WAS RETRIEVED AND ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600488 ↗
• MalfunctionJul 21, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROMONTOFIXATION, THE RELOAD BROKE WHILE LOADING. THE DEVICE WAS NOT USED IN THE PATIENT. THE SURGEON USED ANOTHER PRODUCT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075421 ↗
• MalfunctionDec 15, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA TRANSABDOMINAL PREPERITONEAL PROCEDURE, STAPLES NO LONGER CLOSE AFTER USING THREE CARTRIDGES. THE SURGEON REPLACED THE DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009550 ↗
• MalfunctionOct 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE LOADING UNIT FELL INTO THE PATIENT¿S CAVITY. THE SURGEON LOOKED FOR IT AND REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666400 ↗
• MalfunctionOct 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA PROCEDURE, STAPLE FELL IN TO THE PATIENT CAVITY AND WAS RETRIEVED BY SEARCHING. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647020 ↗
• MalfunctionJun 4, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, WHEN CLOSING THE TISSUE DURING A LAPAROSCOPIC LEFT INGUINAL HERNIA REPAIR, THE STAPLER FIRED BUT THE STAPLE LEGS FOLDED OUTSIDE INSTEAD OF FOLDING INSIDE LIKE THEY ARE SUPPOSED TO. THEY WENT THROUGH MULTIPLE HANDLES TO COMPLETE THE PROCEDURE. THEY ALSO CONTINUED TO OPEN NEW STAPLES TO BE USED UNTIL THE PATIENT DID NOT NEED ANY. THE MALFUNCTION OCCURRED TWICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942422 ↗
• MalfunctionJun 4, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, WHEN CLOSING THE TISSUE DURING A LAPAROSCOPIC LEFT INGUINAL HERNIA REPAIR, THE STAPLER FIRED BUT THE STAPLE LEGS FOLDED OUTSIDE INSTEAD OF FOLDING INSIDE LIKE THEY ARE SUPPOSED TO. THEY WENT THROUGH MULTIPLE HANDLES TO COMPLETE THE PROCEDURE. THEY ALSO CONTINUED TO OPEN NEW STAPLES TO BE USED UNTIL THE PATIENT DID NOT NEED ANY. THE MALFUNCTION OCCURRED TWICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942399 ↗
• MalfunctionMar 12, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHILE CLOSING THE PERITONEUM, THE DEVICE DID NOT FIRE. THERE WAS AN ODD ¿CRUNCHING¿ SOUND WHEN THE DEVICE WAS FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11476545 ↗
• MalfunctionDec 3, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, WHILE FIRING DURING LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR- TRANSABDOMINAL PREPERITONEAL (TAPP), THE STAPLE DEFORMS AND GET JAMMED IN THE DEVICE. THE SURGEON REMOVED THE JAMMED STAPLE AND REPLACED ANOTHER LOAD AND CONTINUED WITH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9400908 ↗
• InjuryFeb 25, 2019Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE, A TACK FROM THE DEVICE GOT ATTACHED TO TWO SEPARATE PIECES OF BOWEL WHICH CAUSED AN OBSTRUCTION. PATIENT WENT BACK TO THE HOSPITAL AND WAS RE-OPERATED ON TO REMOVE THE TACK.

  Patient problems: No Code Available; Obstruction/Occlusion

  MAUDE report 8368673 ↗
• InjuryFeb 1, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, WHILE CLOSING THE PERITONEUM, THE STAPLES DID NOT FULLY CLOSE LEAVING AN OPENING FOR BOWEL TO GET ENTRAPPED IN. THE ENTRAPPED BOWEL WAS RELEASED WITHOUT ISSUE. THEY HAD TO RE-OPERATE TO REMOVE TRAPPED BOWEL. THE EVENT LEAD TO AN EXTENDED HOSPITAL STAY FOR ONE DAY.

  Patient problems: No Code Available

  MAUDE report 8297033 ↗
• MalfunctionDec 21, 2017Entrapment of Device; Failure to Form Staple; Mechanical Jam; Entrapment of Device; Failure to Form Staple; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA REPAIR, THE STAPLER JAMMED AS IT WAS FIRING A STAPLE TO TACK UP THE MESH INTO THE PATIENT'S ABDOMINAL WALL. TISSUE NEEDED TO BE EXTRACTED TO REMOVE THE STAPLER AND WHEN IT WAS REMOVED THE SCRUB NURSE WAS UNABLE TO REMOVE THE CARTRIDGE. THERE WAS A POOR STAPLE FORMATION AND THEY HAD TO RESECTED AND RE-STAPLED TO BE ABLE TO FIX THE STAPLE LINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient; Tissue Damage

  MAUDE report 7141173 ↗
• MalfunctionOct 30, 2017Detachment Of Device Component; Misfire; Human-Device Interface Problem; Detachment Of Device Component; Misfire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, WHILE CLOSING THE PERITONEUM DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE ON (B)(6) 2017,THE DEVICE PARTIALLY FIRED BUT WAS DIFFICULT TO LOAD. SOME STAPLE LOADERS FELL INTO THE PATIENT'S CAVITY BUT ALL HAVE BEEN RETRIEVED BY THE SURGEON DURING THE SURGERY. THE SURGEON USED 3 LOADERS WITH THE SAME DEVICE TO COMPLETE THE PERITONEUM CLOSURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6986912 ↗
• MalfunctionSep 20, 2017Misfire; Misfire

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC PROMONTOFIXATION. WHILE TRYING TO CLOSE THE PERITONEUM, THE DEVICE PARTIALLY FIRED. TO COMPLETE THE CLOSURE, ANOTHER DEVICE WAS USED. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6880773 ↗

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