MaxTack MAXTACK30Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10884521826267), received between Sep 30, 2024 and Sep 29, 2026 — classified as 1 injury, 42 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (12 reports).

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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Positioning Failure; Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938204 ↗
• MalfunctionJul 30, 2026Display or Visual Feedback Problem; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50085587 ↗
• MalfunctionJul 7, 2026

  PATIENT WAS BROUGHT TO THE OPERATING ROOM AND PLACED SUPINE ON THE OPERATING TABLE. TIME OUT WAS PERFORMED AND GENERAL ANESTHESIA WAS GIVEN. EXCERPTS FROM SURGEON'S NOTES: ATTENTION WAS NEXT DIRECTED AT REPAIR. THE ABSORBABLE LAPAROSCOPIC TACKING DEVICE WAS USED TO CIRCUMFERENTIALLY TACK THE MESH INTO PLACE. ISSUE: MAXTACK NOT FIRING. THE DEVICE WAS CHANGED WITH ANOTHER DEVICE AND THE PROCEDURE WAS DONE WITHOUT FURTHER INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25731867 ↗
• MalfunctionJun 20, 2026Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, WHEN THE ABDOMINAL SCAR HERNIA WAS COVERED WITH A MESH AND FIXED USING A POWERED TACKER, THE WING PART OF THE TACK BROKE AND FELL INTO THE PATIENT. THE SAME THING OCCURRED WITH THE SECOND DEVICE. THE BROKEN FRAGMENTS WERE RETRIEVED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 25569052 ↗
• MalfunctionJun 20, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, WHEN THE ABDOMINAL SCAR HERNIA WAS COVERED WITH A MESH AND FIXED USING A POWERED TACKER, THE WING PART OF THE TACK BROKE AND FELL INTO THE PATIENT. THE SAME THING OCCURRED WITH THE SECOND DEVICE. THE BROKEN FRAGMENTS WERE RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25569049 ↗
• MalfunctionJun 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR, WHILE ON FIXATION OF A MESH IMPLANT, THE DEVICE WAS SHEARING OFF THE TOP OF THE TACKS. ANOTHER DEVICE WAS PULLED OUT TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25533177 ↗
• MalfunctionMay 19, 2026Positioning Failure; Failure to Advance; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC UMBILICAL HERNIA REPAIR WITH MESH PLACEMENT IN THE IPOM PLANE, THE FIRST TACK MISFIRED, WHICH BUNCHED UP THE MESH. THE SURGEON REMOVED THE TACKER AND FIRED AGAIN, AND IT WORKED THE SECOND TIME, SO USE CONTINUED. THE FIFTH TACK DID NOT DEPLOY AND THE DEVICE INDICATOR LIGHT TURNED RED DURING USE. A NEW TACKER WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216116 ↗
• MalfunctionApr 24, 2026

  FAILED DURING USE, FAILED TO FIRE.

  Patient problems: Insufficient Information

  MAUDE report 24980112 ↗
• MalfunctionApr 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) PROCEDURE, TACKS FROM THE DEVICE FELL INTO THE CAVITY OF THE PATIENT. THE TACKS WERE SUBSEQUENTLY RETRIEVED FROM THE PATIENT. A NEW TACKER FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847552 ↗
• MalfunctionApr 6, 2026Failure to Advance

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA, DURING MESH FIXATION, THE TACK HAS GONE THROUGH THE PORE OF MESH WITHOUT FIXATING THE MESH ONTO PATIENT THE SURGEON FIRE ONE MORE TACK ON THE MESH TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789762 ↗
• MalfunctionApr 3, 2026Failure to Advance

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC INCISIONAL HERNIA REPAIR, WHEN ON THE MESH FIXATION, THE TACK WAS NOT PROPERLY PLACED ONTO TISSUE, AND DID NOT FIXATE THE MESH. ANOTHER TACK WAS FIRED TO THE MESH TO COMPLETE THE MESH FIXATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781849 ↗
• MalfunctionMar 30, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING MESH FIXATION IN A LAPAROSCOPIC IPOM (INTRAPERITONEAL ONLAY MESH (IPOM) HERNIA REPAIR USING THE POWERED TACKER, WHEN THE TACKER PUSH BUTTON WAS PRESSED, TWO TACKS DEPLOYED SIMULTANEOUSLY. THE DEVICE WAS REPLACED WITH ANOTHER TACKER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713630 ↗
• MalfunctionMar 9, 2026Failure to Advance

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INCISIONAL HERNIA PROCEDURE, UPON FIXATING THE MESH TO THE ABDOMINAL WALL, FOUR TACKS PENETRATED THROUGH THE MESH AND TORE THREADS OF MESH, WHICH RESULTED TO THE MESH NOT FIXATING TO THE ABDOMINAL WALL. MORE TACKS WERE DEPLOYED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551811 ↗
• MalfunctionMar 4, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL WALL SCAR HERNIA REPAIR, WHEN EXPANDING THE MESH AND PERFORMING TACKING, THE TACK BROKE PARTWAY, AND ONLY THE HEAD PORTION REMAINED IN THE TACKER HANDLE. ANOTHER MOTORIZED TACKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24504496 ↗
• MalfunctionFeb 4, 2026Display or Visual Feedback Problem; Detachment of Device or Device Component; Noise, Audible

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC VENTRAL HERNIA PROCEDURE, TWO TACKS DEPLOYED SIMULTANEOUSLY FROM THE DEVICE WHILE BEING APPLIED TO THE ABDOMINAL WALL. THE TOP OF THE TACKS DISENGAGED INTO THE CAVITY OF THE PATIENT AND WERE SUBSEQUENTLY RETRIEVED. THE DEVICE INDICATOR LIGHT DID NOT SIGNAL AN ERROR DURING THE MALFUNCTION AND REMAINED GREEN THROUGHOUT THE EVENT. AFTER REMOVAL, THE DEVICE WAS DRY FIRED TO TEST ITS FUNCTION; TWO TEAL TACKS REMAINED AND WERE FIRED, AFTER WHICH THE DEVICE INDICATED IT WAS EMPTY WITH A RED LIGHT AND AUDIBLE NOISE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24257703 ↗
• MalfunctionJan 30, 2026Positioning Failure; Display or Visual Feedback Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE POWERED TACKER WAS REMOVED AFTER A YELLOW LIGHT APPEARED AND NO TACK DEPLOYED. FOLLOWING THE REMOVAL, MULTIPLE ATTEMPTS WERE MADE TO FIRE THE DEVICE. ON THE THIRD ATTEMPT, MULTIPLE TACKS WERE EXPELLED FROM THE DEVICE ONTO THE FLOOR. AT THAT POINT, THE DECISION WAS MADE TO DISCONTINUE USE AND OPEN A NEW TACKER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223185 ↗
• MalfunctionJan 16, 2026Positioning Failure; Misfire; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) REPAIR, AT THE TIME OF FIRING, THE MOTORIZED TACKER HAD AN ISSUE. THE ISSUE WAS RESOLVED BY USING ANOTHER TACKER TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 24103629 ↗
• MalfunctionJan 14, 2026Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TACKER MISFIRED WHEN FIRED AT AN INCORRECT ANGLE, RESULTING IN A LOOSE TACK. THE LOOSE TACK WAS SUBSEQUENTLY REMOVED FROM THE PATIENT AND DISCARDED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 24073156 ↗
• MalfunctionDec 19, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) PROCEDURE, WHILE TACKING THE MESH, THE TACKS FELL INTO THE CAVITY OF THE PATIENT. THE TACKS WERE RETRIEVED FROM THE PATIENT WITH THE HELP OF GRASPERS. ANOTHER TACKER WAS USED TO COMPLETETHE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847297 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN NEAR THE SURGICAL SITE FOLLOWING A PROCEDURE. CONCOMITANT MEDICATION WAS ADMINISTERED OR ADJUSTED IN RESPONSE TO THIS ADVERSE EVENT. THE PATIENT WAS REPORTED TO BE RECOVERING OR RESOLVING FROM THE EVENT. THE ADVERSE EVENT HAD POSSIBLE RELATION TO THE DEVICE AND TO THE STUDY PROCEDURE.

  Patient problems: Abdominal Pain

  MAUDE report 23693304 ↗
• MalfunctionNov 13, 2025Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH REPAIR, WHILE FIXING THE MESH, THE MOTORIZED TACKER FIRED CONT INUOUSLY WITHOUT THE SURGEON PRESSING THE FIRING TRIGGER, RESULTING IN THE AUTOMATIC AND UNINTENTIONAL RELEASE OF MULTIPLE TACKS. THE SURGEON REMOVED THE TACKER AND SET IT ASIDE TO PREVENT FURTHER RISK, AND ANOTHER PRODUCT OF THE SAME CODE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23539433 ↗
• MalfunctionNov 7, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC HERNIA REPAIR, THE MOTORIZED STRAIGHT FIXATION DEVICE COULD NOT FIT THROUGH A 5MM. PORT DUE TO THE PORT DESIGN. THE ISSUE WAS RESOLVED BY USING ANOTHER COMPANY¿S DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501493 ↗
• MalfunctionNov 7, 2025Display or Visual Feedback Problem; Failure to Advance; Display or Visual Feedback Problem; Failure to Advance

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC VENTRAL HERNIA, DURING MESH FIXATION, THERE WERE INSTANCES WHERE THE DEVICE WAS DOUBLE FIRING, AND NOT FULLY DEPLOYING IN OTHER ACTUATIONS. THE DOUBLE FIRED TACKS FELL INTO THE CAVITY AND WERE RETRIEVED WITH GRASPERS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494768 ↗
• MalfunctionNov 3, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHILE ON MESH TACKING, THE PRESSING FORCE WAS STRONG, AND PENETRATED THE MESH AND EMBEDDED IN THE COOPER'S LIGAMENT BUT THE HEAD BROKE. THE BROKEN HEAD FELL INTO THE PATIENT'S CAVITY AND RETRIEVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458938 ↗
• MalfunctionOct 27, 2025Battery Problem; Power Problem

  WHEN SURGEON ACTIVATED THE BATTERY POWERED MAXTACK TACKER TO EXPEL A TEST TACK ONTO THE MAYO STAND, THE TACKER DID NOT TURN OFF. IT CONTINUED EXPELLING TACK AFTER TACK UNTIL ALL 30 WERE EXPELLED ONTO THE MAYO STAND. IT CONTINUED RUNNING. MEANWHILE, THE BATTERY POWERED TACKER MOTOR IS STILL RUNNING. CIRCULATOR HAD TO REMOVED BATTERIES TO GET IT TO TURN OFF. THE BATTERIES WERE EXTREMELY HOT. THE TACKS WERE COLLECTED FROM THE FIELD, PLACED IN PLASTIC BAG, AND ALSO PUT BACK IN ORIGINAL PACKAGING WITH TACKER (A COUPLE OF TACKS FELL ON FLOOR AND WERE NOT RECOVERED). THE MALFUNCTIONING TACKER HAD NO CONTACT WITH THE PATIENT AT ANY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390094 ↗