ReliaTack RELTACK3X10Recalls & reported problems

Summary

The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 10884521202399), received between Jan 31, 2017 and Apr 28, 2026 — classified as 10 injuries, 169 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (96 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. 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 179 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TEP INGUINAL HERNIA PROCEDURE USING THE TACKER ARTICULATING RELOAD, AT THE FIRING OF THE FIRST INITIAL TACK, THE RELOAD DISENGAGED INTO THE PATIENT CAVITY AND MICRO PLASTIC FELL INTO THE PATIENT CAVITY. THE SURGEON REMOVED THE PLASTIC. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016208 ↗
• MalfunctionJan 15, 2026Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA MESH IMPLANTATION, THE THREE RELOADS WERE DIFFICULT TO LOAD ONTO THE ARTICUL ATING TIP OF THE HANDLE. THE DEVICES WERE STILL ABLE TO BE USED ON THE PATIENT. THREE NEW RELOADS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079447 ↗
• MalfunctionJan 15, 2026Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA MESH IMPLANTATION, THE THREE RELOADS WERE DIFFICULT TO LOAD ONTO THE ARTICUL ATING TIP OF THE HANDLE. THE DEVICES WERE STILL ABLE TO BE USED ON THE PATIENT. THREE NEW RELOADS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079441 ↗
• MalfunctionJan 15, 2026Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA MESH IMPLANTATION, THE THREE RELOADS WERE DIFFICULT TO LOAD ONTO THE ARTICUL ATING TIP OF THE HANDLE. THE DEVICES WERE STILL ABLE TO BE USED ON THE PATIENT. THREE NEW RELOADS WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079410 ↗
• MalfunctionJan 14, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT PREOPERATIVELY, THE DEVICE COULD NOT BE REFILLED DURING THE PLACEMENT OF WALL REINFORCEMENT. FROM THE OUTSET, IT WAS IMPOSSIBLE TO REFILL THE DEVICE WITH THE PROVIDED REFILLS, AND DIFFICULTIES WERE ENCOUNTERED WHEN LOADING THE RELOAD ONTO THE HANDLE. THE RELOAD WAS NOT SECURELY FASTENED ONTO THE SHAFT, AND THERE WAS DIFFICULTY ARTICULATING THE DEVICE. ANOTHER DEVICE WAS USED INSTEAD. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24064553 ↗
• MalfunctionNov 20, 2025Device Difficult to Setup or Prepare; Product Quality Problem; Material Twisted/Bent; Device Difficult to Setup or Prepare; Product Quality Problem; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL WALL INCISIONAL HERNIA REPAIR, AFTER 50 SHOTS WITH THE HANDLE, WHEN AN AT TEMPT WAS MADE TO ATTACH THE INCLUDED RELOAD, IT COULD NOT BE FIXED AND COULD NOT BE LOADED. ADDITIONALLY, THE ORIENTATION OF THE PIN WAS NOT VERTICAL. ANOTHER HANDLE WAS THEN USED WITH THE RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610496 ↗
• MalfunctionJul 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A COELIOSCOPIC INGUINAL HERNIA REPAIR, BEFORE USING ON THE PATIENT ON THE OPERATING ROOM TABLE, THE THIRD RELOAD WAS UNABLE TO BE FIXED ON THE DEVICE. THE RELOAD WAS SUCCESSFULLY LOADED INTO A NEW HANDLE AND WAS ABLE TO BE USED ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22417509 ↗
• MalfunctionJun 16, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A VENTRAL HERNIA REPAIR, THE TACKS CAME OUT BUT DID NOT ATTACH TO THE WALL. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216203 ↗
• MalfunctionJun 2, 2025Positioning Failure; Display or Visual Feedback Problem; Failure to Advance; Positioning Failure; Display or Visual Feedback Problem; Failure to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TACKS CAME OUT BUT DID NOT ATTACH TO THE WALL.

  Patient problems: Insufficient Information

  MAUDE report 22129284 ↗
• MalfunctionAug 26, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ABDOMINAL INCISIONAL HERNIA, WHEN REPLACING THE CARTRIDGE, THE ATTACHMENT PART ROTATED, MAKING IT DIFFICULT TO INSTALL THE CARTRIDGE. NORMALLY, IT SHOULD NOT ROTATE. BECAUSE IT ROTATED, THE ARROWS COULD NOT BE FIRMLY FIXED TOGETHER. THE TACK DID NOT COME OUT AND MADE THE TACKING DIFFICULT, BUT THE SURGEON STILL MANAGED TO USE THE DEVICE AND CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20066076 ↗
• MalfunctionJul 26, 2024Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA CURE WITH MESH PLACEMENT, THE RELOAD HAD LOADING DIFFICULTY; IT WOULD NOT SECURELY FASTEN TO THE SHAFT. IN THE ABDOMINAL WALL, THE RELOAD FELL INTO THE PATIENT'S CAVITY. THE SURGEON HAD DIFFICULTY FINDING THE RELOAD AND THEN EXTRACTING IT THROUGH A TROCAR. THE SURGEON WAS STILL ABLE TO REMOVE THE DEVICE; A DIFFERENT TYPE OF TACKER WAS THEN USED. THE PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839251 ↗
• MalfunctionJul 3, 2024Device Difficult to Setup or Prepare; Positioning Problem; Device Difficult to Setup or Prepare; Positioning Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC VENTRAL HERNIA REPAIR, THE FIRST TACK RELOAD WAS PROPERLY FIRED. HOWEVER, THE SECOND TACK RELOAD COULD NOT BE FASTENED. THERE WAS DIFFICULTY IN LOADING THE RELOAD ONTO THE HANDLE DURING PREPARATION. AFTER THE LOADING ISSUES WERE EXPERIENCED, THE RELOAD WAS USED IN THE PATIENT. THE DEVICE WAS ALSO DIFFICULT TO ARTICULATE. THE SECOND TACK RELOAD COULD NOT BE FASTENED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19671904 ↗
• MalfunctionJun 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH REPAIR (IPOM) PROCEDURE, WHEN THE SURGEON WANTED TO TACK THE MESH, THE RELOAD DISENGAGED AND FELL INTO THE SITUS (CAVITY). THE SURGEON REMOVED THE RELOAD FROM THE PATIENT AND USED A NEW TACKER WITH A DIFFERENT PRODUCT ID TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19595897 ↗
• MalfunctionJan 12, 2024Device Difficult to Setup or Prepare; Difficult or Delayed Activation; Firing Problem; Device Difficult to Setup or Prepare; Difficult or Delayed Activation; Firing Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL WALL SCAR HERNIA REPAIR, WHEN ATTACHING THE RELOAD THAT HAS 10 FIRINGS TO THE HANDLE AND WHILE PRESSING THE RED FIRE BUTTON, THE BUTTON WAS HARDER TO PRESS THAN USUAL. THE USER MANAGED TO FORCEFULLY PUSH IT IN AND, FORTUNATELY, WAS ABLE TO USE IT NORMALLY. AFTER THAT, THE RELOAD WAS REPLACED, BUT IT WAS DIFFICULT TO RELOAD. IT WAS NOTED THAT THERE WAS DIFFICULTY PUSHING THE "PUSH TO RELOAD" BUTTON, AND THE LOCK AND UNLOCK BUTTON WAS DIFFICULT TO OPERATE AS WELL. FIRING WAS CONTINUED, AND AS EXPECTED, THE RED BUTTON WAS STILL HARD, AND THE DOCTOR HAD TO APPLY A LOT OF FORCE TO PUSH IT IN. THE OPERATION ITSELF WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502819 ↗
• MalfunctionNov 30, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL INCISIONAL HERNIA SURGERY, WHEN FIXATING THE MESH, AT THE TIME OF REPLACEMENT AND WHEN THE CARTRIDGE WAS ATTACHED, THE BLUE PART WOULD NOT RETURN AND THE TIP DID NOT ATTACH. TO RESOLVE THE ISSUE, THE HANDLE WAS CHANGED AND THE SAME RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243072 ↗
• InjuryJul 26, 2023Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component; Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA REPAIR, THREE TACKERS WERE USED BUT TACKS WERE NOT STICKING AS REQUIRED AND DISINTEGRATING WHEN USED. THE TACKS FELL INTO THE PATIENT AND WERE NOT RETRIEVED. ANOTHER TACKER WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17397968 ↗
• MalfunctionJun 16, 2023Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem; Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC INCISIONAL HERNIOPLASTY PROCEDURE WHEN APPLYING THE TACKS ON THE MESH, BOTH DEVICE HAD DIFFICULTY LOADING THE RELOAD ONTO THE HANDLE AND RELOAD WAS NOT SECURELY FASTENED ONTO THE SHAFT. IT WAS NOTED THAT IN ONE OF THE DEVICE, NONE OF THE TACKS WAS ABLE TO BE FIRED NORMALLY FROM THE DEVICE. THE SURGICAL TIME WAS 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148889 ↗
• MalfunctionJun 16, 2023Positioning Failure; Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Device Difficult to Setup or Prepare; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC INCISIONAL HERNIOPLASTY PROCEDURE WHEN APPLYING THE TACKS ON THE MESH, BOTH DEVICE HAD DIFFICULTY LOADING THE RELOAD ONTO THE HANDLE AND RELOAD WAS NOT SECURELY FASTENED ONTO THE SHAFT. IT WAS NOTED THAT IN ONE OF THE DEVICE, NONE OF THE TACKS WAS ABLE TO BE FIRED NORMALLY FROM THE DEVICE. THE SURGICAL TIME WAS 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17148843 ↗
• InjuryFeb 14, 2023Positioning Failure; Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Positioning Failure; Product Quality Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ABDOMINAL INCISIONAL HERNIA, THE TACKER WAS PLACED TO FIXATE THE ABDOMINAL WALL, ATTEMPTED TO ARTICULATE BUT IT DID NOT ARTICULATE AND DID NOT FIRE. WHEN THE CARTRIDGE WAS REMOVED AND CHECKED, IT WAS CONFIRMED THAT THERE WAS NO SCREW. THE PHYSICIAN DID NOT KNOW IF IT WAS NOT THERE FROM THE BEGINNING OR HAD FALLEN. AN X-RAY WAS TAKEN TO CONFIRM BUT IT DID NOT SHOW UP. A NEW TACKER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 16372175 ↗
• MalfunctionNov 2, 2022Device Difficult to Setup or Prepare; Difficult or Delayed Activation; Component or Accessory Incompatibility; Adverse Event Without Identified Device or Use Problem; Device Difficult to Setup or Prepare; Difficult or Delayed Activation; Component or Accessory Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR, WHEN TACKING MESH IN PLACE OVER HERNIA, THE FIRST TEN (10) TACKS WORKED PERFECTLY. AFTERWARDS, THERE WAS DIFFICULTY LOADING THE RELOAD ONTO THE HANDLE. THE SECOND RELOAD WAS NOT SECURELY FASTENED ONTO THE SHAFT. THERE WAS DIFFICULTY NAVIGATING THE LOCK AND UNLOCK BUTTON. THE DEVICE WAS NOT USED IN THE PATIENT DUE TO THE ISSUE. TO RESOLVE THE ISSUE, ANOTHER TACKER OF A DIFFERENT TYPE WAS USED. THE SURGERY WAS EXTENDED FOR 30 MINUTES OR MORE AS THE USER STRUGGLED LOADING THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15718109 ↗
• MalfunctionNov 2, 2022Device Difficult to Setup or Prepare; Component or Accessory Incompatibility; Device Difficult to Setup or Prepare; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC HERNIA REPAIR, WHILE IN THE ABDOMINAL WALL, THERE WERE DIFFICULTIES WITH LOADING THE RELOAD ONTO THE HANDLE. AFTER THE LOADING ISSUES, THE RELOAD WAS NOT USED IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716148 ↗
• MalfunctionSep 20, 2022Break; Human-Device Interface Problem; Physical Resistance/Sticking; Break; Human-Device Interface Problem; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ABDOMINAL INCISIONAL HERNIA REPAIR, WHEN TACKING, THERE WAS DIFFICULTY ARTICULATING THE DEVICE. THE ARTICULATED KNOB BECAME UNABLE TO WORK, AND BECAME UNAPPROACHABLE. IT HAPPENED ON THE SECOND CARTRIDGE, SO IT WAS UNABLE TO BE APPROACHED STRAIGHT. A NEW TACKER WAS TAKEN OUT AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455808 ↗
• MalfunctionJun 28, 2022Device Difficult to Setup or Prepare; Component or Accessory Incompatibility; Device Difficult to Setup or Prepare; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA REPAIR WHILE TACKING THE MESH INTO THE MUSCLE LAYER, AFTER FIRING 10 TACKS THE SECOND RELOAD WOULD NOT ATTACH TO THE HANDLE. TO RESOLVE THE ISSUE, ANOTHER TACKER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842244 ↗
• MalfunctionMay 31, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA SURGERY, AFTER INTRODUCING THE MESH, THE DEVICE WAS DIFFICULT TO LOAD. THE SURGEON HAD DIFFICULTY PRESSING THE PUSH TO RELOAD BUTTON AND NAVIGATING WITH THE LOCK AND UNLOCK BUTTON. THE SURGEON STOPPED USING THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14550701 ↗
• MalfunctionMay 3, 2022Device Difficult to Setup or Prepare; Physical Resistance/Sticking; Device Difficult to Setup or Prepare; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, AFTER REMOVING THE CARTRIDGE WITH 0 TACK AND AFTER ATTEMPTING TO LOAD A NEW CARTRIDGE, THE HANDLE AND CARTRIDGE COULD NOT BE ATTACHED. THE NURSE WAS ABLE TO PRESS THE RED BUTTON AND SQUEEZE THE HANDLE TO THE END, AND MAKE THE TIP PIN IN THE VERTICAL POSITION WITH THE SHAFT MARK, BUT THE TIP PIN DID NOT RETURN TO THE POSITION WHERE THE CARTRIDGE COULD BE LOADED, SO IT COULD NOT BE LOADED. AFTER THE LOADING ISSUE OCCURRED, THE RELOAD WAS USED. A NEW TACKER WAS TAKEN OUT AND THE CASE WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269726 ↗