ReliaTack RELTACK4xDPTSWRecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10884521726383), received between May 16, 2018 and Oct 10, 2024 — classified as 2 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (24 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2024Failure to Advance; Failure to Advance

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHEN THE DEVICE WAS FIRED ON THE PUBIC BONE DURING MESH FIXATION, THE TACK JAMMED AND DID NOT FULLY RELEASE FROM THE DISTAL END OF THE SHAFT. THE SURGEON APPLIED FORCE TO DISENGAGE THE TACK. ANOTHER TACKER WAS USED AND WORKED FINE WHEN FIRED ON THE RECUTS MUSCLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20415520 ↗
• MalfunctionSep 17, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC VENTRAL HERNIA REPAIR, DURING HERNIA MESH FIXATION, THE DEVICE WOULD NOT LOAD ONTO THE HANDLE. IT WAS NOTED THAT AFTER THE LOADING ISSUES WERE EXPERIENCED, THE RELOAD WAS NOT USED IN THE PATIENT. A NEW ONE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241667 ↗
• MalfunctionApr 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, WHEN THE SURGEON WAS TRYING TO SECURE THE MESH INTO PLACE. THE SURGEON NOTED THAT THE TACKER WAS NOT FIRING APPROPRIATELY AS THE TACKS REMAINED PARTIALLY IN THE SHAFT OF THE DEVICE AND THEY WERE NOT FULLY ENGAGING THE TISSUE. THE MESH WAS UNABLE TO BE SECURED WITH THE DEVICE SO A DIFFERENT TACKER WAS USED TO RESOLVE THE ISSUE. THE SURGEON HAD TO SPEND AN ADDITIONAL 30 MINUTES TO THE SURGICAL TIME TRYING TO GET THE TACKER TO WORK, REMOVING THE INADEQUATELY SECURED TACKS, THEN RE-TACKING THE MESH WITH A DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19194064 ↗
• MalfunctionJan 19, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, UPON FIXATION, THE TACKS WOULD NOT LOAD CORRECTLY AND WAS UNABLE TO LOAD. ANOTHER DEVICE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18548285 ↗
• MalfunctionNov 14, 2023Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, WHILE SECURING THE MESH INTO PLACE, THE TACKER WAS NOT FIRING APPROPRIATELY; THE TACKS REMAINED PARTIALLY IN THE SHAFT OF THE DEVICE AND WERE NOT FULLY ENGAGING INTO THE TISSUE. THE SURGEON TRIED TO GET THE TACKER TO WORK BY REMOVING THE INADEQUATELY SECURED TACKS AND THEN RE-TACKING THE MESH WITH ANOTHER TACKER. THIS LED TO ABOUT 30 MINUTES EXTENDED SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18133299 ↗
• MalfunctionAug 23, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UMBILICAL HERNIA PROCEDURE, THE ISSUE OCCURRED DURING THE STEP OF MESH FIXATION WITH A TACKER. THE PROBLEM WAS THAT THE PIN IN THE SHAFT OF THE TACKER WOULD NOT ALIGN CORRECTLY, PREVENTING THE NORMAL LOADING OF THE DEVICE. HOWEVER, AFTER MULTIPLE ATTEMPTS AND CYCLING THE DEVICE NUMEROUS TIMES, IT EVENTUALLY STARTED WORKING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17604145 ↗
• MalfunctionJul 6, 2023Component or Accessory Incompatibility; Human-Device Interface Problem; Component or Accessory Incompatibility; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, WHEN THE PRODUCT WAS OPENED ON THE SURGICAL FIELD, THE PORTION OF THE DEVICE USED TO MATE TO THE STAPLE LOAD WAS ROTATED OUT OF VERTICAL POSITION TO A NEAR HORIZONTAL POSITION. ATTEMPTS TO ROTATE TO A VERTICAL POSITION FAILED. THE RELOAD WAS UNABLE TO BE CONNECTED TO THE HANDLE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 17268046 ↗
• MalfunctionMay 26, 2023Positioning Failure; Device Difficult to Setup or Prepare; Positioning Failure; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INCISIONAL PROCEDURE, WHILE TACKING IN THE MESH, THE TRIGGER WAS HARD TO ENGAGE INITIALLY AND THE USER DID HEAR THE CLICK, BUT WHEN PULLED BACK, THE TACK WOULD NOT RELEASE. THE DOCTOR TRIED MULTIPLE TIMES. ANOTHER WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17014490 ↗
• MalfunctionApr 19, 2023Activation Failure

  PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE SHE WAS PLACED IN SUPINE POSITION. GENERAL ANESTHESIA WAS INDUCED. THE ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. PROCEDURE STARTED AND THE ABDOMEN WAS INSUFFLATED. TROCARS WERE INSERTED. LYSIS OF ADHESIONS WAS PERFORMED INITIALLY. WHEN IT WAS TIME TO USE THE RELIATACK FIXATION DEVICE, IT WAS NOT FUNCTIONING AT ALL. PHYSICIAN SAID THAT THE MECHANISM ON THE END WAS NOT ACTIVATING THE TACKS. THE DEVICE WAS REPLACED WITH A SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED AS PLANNED. NO PATIENT HARM. MANUFACTURER RESPONSE FOR STAPLE, IMPLANTABLE, RELIATACK (PER SITE REPORTER). DEVICE TAKEN BY MEDICAL REPRESENTATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768221 ↗
• MalfunctionMar 10, 2023Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, WHILE ATTEMPTING TO TACK THE MESH IN PLACE WITH THE TACKER, THE TACKER FIRED THE TACK AND THEN THE LOAD DISCONNECTED INSIDE THE PATIENT. NO OTHER BUTTONS WERE PUSHED DURING THE FIRING. THIS RESULTED IN THE FRONT HALF OF THE TACKER STUCK TO THE TACK WHICH WAS IN THE BONE HOLDING THE MESH IN PLACE. THE SURGEON HAD TO MANUALLY UNSCREW THE FRONT PART OF THE TACKER AND REMOVE FROM THE PATIENT'S BODY. SUBSEQUENTLY SWITCHED TO ANOTHER TACKER WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16525477 ↗
• MalfunctionDec 26, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A LAB NISSEN FUNDOPLICATION, THE TACKS WERE BENT WHEN DISCHARGED. THERE WERE TACKS THAT WERE NOT ABLE TO FIRE NORMALLY FROM THE DEVICE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16046758 ↗
• MalfunctionDec 26, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TACKS WERE BENT WHEN DISCHARGED. THERE WERE TACKS NOT ABLE TO FIRED NORMALLY FROM THE DEVICE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16046735 ↗
• MalfunctionDec 20, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TACKS WERE BENT WHEN DISCHARGED. THERE WERE TACKS NOT ABLE TO FIRED NORMALLY FROM THE DEVICE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16017011 ↗
• MalfunctionDec 19, 2022Loss of or Failure to Bond; Difficult or Delayed Activation; Component or Accessory Incompatibility; Loss of or Failure to Bond; Difficult or Delayed Activation; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, WHILE AT MESH FIXATION, FOR THE TWO DEVICES, THE TACK DID NOT FULLY RELEASE FROM THE TIP OF THE SHAFT WHEN FIRED INTO THE PUBIC BONE, AND THE SCRUB TECHNICIAN ALSO HAD ISSUES LOADING BOTH. THE RELOADS WOULD FULLY ENGAGE AND LOCK ON THE TIP OF THE DEVICE, THEY REPEATEDLY SLIPPED OFF. AFTER THE LOADING ISSUES WERE EXPERIENCED, THE RELOAD WAS NOT USED IN THE PATIENT. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16006230 ↗
• MalfunctionDec 19, 2022Loss of or Failure to Bond; Difficult or Delayed Activation; Component or Accessory Incompatibility; Loss of or Failure to Bond; Difficult or Delayed Activation; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, WHILE AT MESH FIXATION, FOR THE TWO DEVICES, THE TACK DID NOT FULLY RELEASE FROM THE TIP OF THE SHAFT WHEN FIRED INTO THE PUBIC BONE, AND THE SCRUB TECHNICIAN ALSO HAD ISSUES LOADING BOTH. THE RELOADS WOULD FULLY ENGAGE AND LOCK ON THE TIP OF THE DEVICE, THEY REPEATEDLY SLIPPED OFF. AFTER THE LOADING ISSUES WERE EXPERIENCED, THE RELOAD WAS NOT USED IN THE PATIENT. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16006128 ↗
• MalfunctionNov 4, 2022Loss of or Failure to Bond; Device Difficult to Setup or Prepare; Loss of or Failure to Bond; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHILE ON MESH FIXATION, THE TACKS DID NOT FULLY DEPLOY FROM THE DEVICE, IT HALF FIRED. THE OPERATING ROOM TEAM TRIED TO RELOAD THE SAME DEVICE AND THE RELOAD WOULD NOT INITIALLY STAY ON THE SHAFT. EVENTUALLY, IT WAS SUCCESSFULLY RELOADED AND THE SAME ISSUE OCCURRED, THE TACK WOULD NOT FULLY DEPLOY. A NEW TACKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15739510 ↗
• MalfunctionJun 13, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE WAS BROKEN.

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

  MAUDE report 14679659 ↗
• MalfunctionJun 6, 2022Loss of or Failure to Bond; Noise, Audible; Loss of or Failure to Bond; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA, WHILE AT FIXATION OF MESH, WHEN FIRED, THE TACK DID NOT FULLY FIRE. THE TOP PART PENETRATED THROUGH THE MESH, THE REST OF THE TACK DID NOT RELEASE FROM THE SHAFT. THERE WAS ALSO A VERY LOUD CRACK WHEN THE SURGEON INITIALLY FIRED THE DEVICE FOLLOWED BY ADDITION CRACK LIKE NOISES WHEN THE SURGEON FIRED THE DEVICE. THE SURGEON STOPPED USING AFTER ONE FIRING ATTEMPT. THE DEVICE WAS PULLED WITH FORCE AWAY FROM THE MESH. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14604802 ↗
• MalfunctionAug 11, 2021Break; Component or Accessory Incompatibility; Positioning Problem; Break; Component or Accessory Incompatibility; Positioning Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VENTRAL HERNIA, ON THE FINAL STEP OF SECURING MESH TO ABDOMINAL WALL, THERE WAS DIFFICULTY WITH LOADING THE RELOAD ONTO THE HANDLE AND IN ARTICULATING THE DEVICE. SPRING ON DEVICE DEEP PURCHASES TACKER BROKE AND JAMMED. SURGEON OPENED ANOTHER TACKER HANDLE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306836 ↗
• MalfunctionMay 17, 2021Difficult or Delayed Positioning; Device Difficult to Setup or Prepare; Material Twisted/Bent; Difficult or Delayed Positioning; Device Difficult to Setup or Prepare; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC INGUINAL VENTRAL HERNIA REPAIR, WHEN MESH WAS BEING FIXATED, THE HANDLE WAS SQUEEZE, THERE WAS DIFFICULTY SQUEEZING IT SLOWLY AND TORQUING AND USING TOO MUCH COUNTER PRESSURE AT THE SAME TIME. THE RELOAD THEN BENT IN THE MIDDLE OF THE SHAFT (NOT WHERE IT CONNECTS TO THE TACKING DEVICE). THERE WAS ALSO DIFFICULTY WITH LOADING THE RELOAD ONTO THE HANDLE AND IN PRESSING THE "PUSH TO RELOAD" BUTTON. AFTER THE LOADING ISSUES WERE EXPERIENCED, THE RELOAD WAS USED IN THE PATIENT. NEW TACKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832755 ↗
• MalfunctionMar 17, 2021Positioning Failure; Device Difficult to Setup or Prepare; Positioning Failure; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC UMBILICAL HERNIA REPAIR, THE SURGEON WAS ABLE TO FIRE THE TACKS, BUT UNABLE TO FIRE THE LAST FEW TACKS, APPROXIMATELY 5 TACKS. THERE WAS ALSO DIFFICULTY IN LOADING THE RELOAD ONTO THE HANDLE. ANOTHER TACKER WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510196 ↗
• MalfunctionJul 16, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, WHILE PLACING THE MESH, THE SURGEON EXPERIENCED DIFFICULTIES WITH LOADING THE RELOAD ONTO THE HANDLE, HOWEVER AFTER THE LOADING ISSUES WERE EXPERIENCED, THE DEVICE STILL USED IN PATIENT. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10284323 ↗
• MalfunctionFeb 14, 2020Component or Accessory Incompatibility; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VENTRAL HERNIA REPAIR, THE SURGEON ATTEMPTED TO LOAD MULTIPLE TACK CARTRIDGES ONTO THE HANDLE, BUT THE PINS IN THE SHAFT WOULD NOT HOLD THE TACK LOADS ONTO THE SHAFT. THE PRODUCT WAS NOT USED IN PATIENT. THE NEW DEVICE WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712860 ↗
• MalfunctionDec 26, 2019Device Difficult to Setup or Prepare; Component or Accessory Incompatibility; Device Difficult to Setup or Prepare; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC UMBILICAL HERNIA PROCEDURE, THE SURGEON WAS UNABLE TO LOAD THE DEVICE WITH THE FIRST RELOAD AS IT WOULD NOT STAY ON. THE SURGEON OPENED A NEW HANDLE AND USED THE ORIGINAL RELOADS AND IT WORKED FINE, AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9519290 ↗
• MalfunctionDec 20, 2019Device Difficult to Setup or Prepare; Difficult or Delayed Activation; Component or Accessory Incompatibility; Human-Device Interface Problem; Device Difficult to Setup or Prepare; Difficult or Delayed Activation; Component or Accessory Incompatibility; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC VENTRAL HERNIA REPAIR, WHILE FIXATING THE MESH, THE ¿PUSH TO RELOAD¿ BUTTON WAS DIFFICULT TO PRESS. THE GREEN AND RED BUTTONS WOULD ALSO NOT TOGGLE BACK AND FORTH. ANOTHER TACKER WAS USED BUT THERE WERE ISSUES WITH THE RELOADS. THE SURGEON TRIED SWITCHING THE STANDARD AND DEEP PURCHASE TACKS; HOWEVER THE RELOADS COULD NOT BE INTERCHANGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9504092 ↗