ReliaTack RELTACK4XDPTRecalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10884521202429), received between Jun 5, 2017 and Aug 27, 2026 — classified as 7 injuries, 106 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (43 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 113 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Device Difficult to Setup or Prepare

  It was reported that during a laparoscopic repair of an incisional hernia of the abdominal wall, when attempting to replace the cartridge for mesh fixation, the cartridge could not be connected to the handle. A new handle was taken out to resolve the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50483679 ↗
• MalfunctionMar 20, 2026Device Difficult to Setup or Prepare; Difficult or Delayed Activation; Component or Accessory Incompatibility

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE FIRST RELOAD WAS CONNECTED PROPERLY TO THE HANDLE, BUT THERE WAS DIFFICULTY CONNECTING THE SECOND RELOAD, THOUGH THE TACKS WERE STILL ABLE TO FIRE NORMALLY. THE THIRD RELOAD COULD NOT BE CONNECTED AT ALL TO THE HANDLE. THERE WAS ALSO DIFFICULTY WITH NAVIGATING THE LOCK AND UNLOCK BUTTON. THE SURGEON, WHO WAS EXPERIENCED WITH THE DEVICE, OPENED ANOTHER TACKER WHICH WAS ABLE TO BE USED WITH NO PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649470 ↗
• MalfunctionFeb 27, 2026Separation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ABDOMINAL WALL INCISIONAL HERNIA SURGERY. A CARTRIDGE REPLACEMENT FOR ALL 29 LONG TACKS INCLUDED IN THE BOX (TOTAL QUANTITY) WAS PERFORMED WITHOUT ANY PROBLEMS. ALL TACKS WERE FIRED WITHOUT ANY MISFIRES, BUT WHEN AN ADDITIONAL CARTRIDGE CONTAINING FIVE TACKS WAS LOADED AND REPLACED, AN ABNORMAL CRACKING SOUND WAS HEARD FROM THE HANDLE. THERE WERE CASES WHERE THE TACKS FELL OUT, AND THE FIXATION WAS LOOSE. THE FALLEN TACKS HAVE BEEN RETRIEVED OUTSIDE THE BODY TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24476376 ↗
• MalfunctionFeb 23, 2026Failure to Advance

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC UMBILICAL HERNIA PROCEDURE, WHEN THE TACKER WAS APPLIED AT THE END OF THE SURGERY TO FIX THE PROSTHESIS, THE TACKS WERE ABLE TO BE FIRED FROM THE DEVICE, BUT NONE WERE ABLE TO PENETRATE OR HOLD ONTO THE TISSUE. THE ISSUE WAS RESOLVED BY TAKING A NEW DEVICE FROM THE SAME LOT 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 24414649 ↗
• MalfunctionDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLOSTOMY PROCEDURE, WHILE MESH FIXATION, BLOOD LOSS OF 500CC OR MORE OCCURRED DUE TO A PROBLEM WITH THE TACKER. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION. THE ISSUE WAS RESOLVED BY USING ANOTHER FIXATION METHOD, SPECIFICALLY GLUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23891534 ↗
• InjuryNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC INCARCERATED VENTRAL HERNIA REPAIR, THE PIN ON THE TACKER THAT HOLDS THE RELOADS BROKE OFF WHEN FIRING AND FELL INTO THE PATIENT¿S CAVITY. X-RAY WAS DONE FOR THE EXPRESS PURPOSE OF LOCATING THE COMPONENT OR CONFIRMING THAT ALL PIECES WERE LOCATED. THE PROCEDURE WAS DELAYED FOR 45 MINUTES DUE TO THE X-RAY. THE PIN WAS FOUND AND A NEW TACKER WAS USED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23539702 ↗
• MalfunctionSep 11, 2025Failure to Advance; Failure to Advance

  ACCORDING TO THE REPORTER, DURING THE LAPAROTOMY WITH ABDOMINAL INCISIONAL HERNIA REPAIR, WHEN THE MESH WAS PLACED, AN ATTEMPT WAS MADE TO SECURE THE MESH. THE TACK WAS FIRED, BUT THE HANDLE WAS UNUSUALLY HARD, AND THE TACK DID NOT COME OFF THE MESH. SEVERAL MORE SHOTS WERE PERFORMED AFTER THAT, BUT DUE TO THE SAME ISSUE, ANOTHER TYPE OF TACKER WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033711 ↗
• MalfunctionJul 30, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR, WHEN FIXING THE MESH, WHEN THE CARTRIDGE WAS BEING INSTALLED, IT COULD NOT BE LOCKED AND FIXED. THE SHAFT WAS STRAIGHT AND VERTICAL, BUT IT WAS NOT FIXED. AFTER SEVERAL ATTEMPTS, IT WAS FIXED, AND IT WAS USED ON THE PATIENT. THE ISSUE OCCURRED ON THE OTHER TWO DEVICES. A DIFFERENT TYPE OF TACKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666400 ↗
• MalfunctionJun 17, 2025No Device Output; Failure to Advance; Component or Accessory Incompatibility; No Device Output; Failure to Advance; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARASTOMAL HERNIA CLOSURE, DURING TACKING OF THE MESH, IT WAS ABLE TO TACK PARTWAY THROUGH, BUT THE HANDLE FELT LIKE AN EMPTY FIRING DURING FIRING. WHEN THE TIP OF THE CARTRIDGE WAS CHECKED, IT WAS FOUND TO BE PROTRUDING. THE CARTRIDGE WAS REMOVED, AND AN ATTEMPT WAS MADE TO REPLACE IT, BUT THE CARTRIDGE COULD NOT BE LOADED, AND ITS USE WAS DISCONTINUED. A SECOND TACKER WAS OPENED; IT WAS ABLE TO TACK PARTWAY THROUGH, BUT SIMILAR TO THE FIRST ONE, THE HANDLE FELT LIKE AN EMPTY FIRING DURING FIRING. THE CARTRIDGE WAS ABLE TO BE CONNECTED; HOWEVER, THE USE WAS DISCONTINUED DUE TO THE EVENT OF THE EMPTY FIRING ISSUE. A NEW TRACKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22230182 ↗
• MalfunctionMay 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL INCISIONAL HERNIA, WHEN THE PRODUCT WAS USED FOR FIRING TO FIXATE ABDOMINAL WALL OF THE MESH, THE TACK INSIDE THE DEVICE WAS DROPPED IN THE ABDOMINAL CAVITY WITHOUT BEING FIRED NORMALLY. IT WAS REMOVED EXTERNALLY WITH NO PROBLEM USING LAPRO CLAMPING FORCEPS. THEY MANAGED TO COMPLETE THE PROCEDURE WITH THE REPORTED TACKS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119530 ↗
• MalfunctionApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TIP BROKE OFF AND FELL INTO PATIENT. THE TIP WAS REMOVED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21896415 ↗
• MalfunctionApr 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC INGUINAL HERNIA REPAIR , DURING MESH FIXATION, THE TIP OF THE TACKER FELL INTO THE PATIENT AND WAS SUBSEQUENTLY REMOVED WITH A LAPAROSCOPIC GRASPER. ADDITIONALLY, THE RELOAD DISENGAGED ALSO INTO THE CAVITY OF THE PATIENT. ANOTHER TACKER WAS OPENED AND 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 21894404 ↗
• MalfunctionApr 4, 2025Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A TEP BILATERAL HERNIA REPAIR USING THE TACKER DEVICE, THE PROBLEM OCCURRED DURING THE FIXATION OF THE MESH IN A LAPAROSCOPIC PROCEDURE. THE SURGEON EXPERIENCED REPEATED MISFIRING AND HAD TO REMOVE THE DEVICE MULTIPLE TIMES TO CLEAR A TACKER BEFORE ATTEMPTING TO FIRE THE NEXT ONE. EVENTUALLY, A NEW TACKER WAS OPENED, AND THE FIXATION WAS COMPLETED WITHOUT FURTHER ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775328 ↗
• MalfunctionMar 25, 2025Device Difficult to Setup or Prepare; Failure to Advance; Device Difficult to Setup or Prepare; Failure to Advance

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE INVOLVING MESH FIXATION, THERE WAS A LOADING ISSUE. SUBSEQUENTLY, THE MESH WAS UNABLE TO PENETRATE THE TISSUE AND HOLD CORRECTLY ONTO THE TISSUE. THE ISSUE WAS RESOLVED BY USING ANOTHER 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 21692803 ↗
• MalfunctionMar 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE USING THE TWO DEVICES, THE LOADING UNITS, FELL INTO THE PATIENT'S CAVITY WHILE TACKING COOPER'S LIGAMENT. THE RELOAD WAS SUCCESSFULLY RETRIEVED, AND A NEW DEVICE 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 21594141 ↗
• MalfunctionMar 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE USING THE TWO DEVICES, THE LOADING UNITS, FELL INTO THE PATIENT'S CAVITY WHILE TACKING COOPER'S LIGAMENT. THE RELOAD WAS SUCCESSFULLY RETRIEVED, AND A NEW DEVICE 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 21594043 ↗
• MalfunctionMar 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHEN ON MESH FIXATION, THE RELOAD FELL OFF SHAFT. THE SURGEON HAD TO RETRIEVE THE RELOAD. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21520978 ↗
• MalfunctionMar 3, 2025Failure to Advance; Component or Accessory Incompatibility; Detachment of Device or Device Component; Positioning Problem; Failure to Advance; Component or Accessory Incompatibility; Detachment of Device or Device Component; Positioning Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, AFTER THE DEVICE WAS FIRED, THE TACK DID NOT FULLY RELEASE FROM SHAFT AND BECAME STUCK IN THE MESH. WHEN THE DEVICE WAS PULLED AWAY FROM THE SURGICAL SITE, THE RELOAD FELL OFF THE SHAFT. THE RELOAD WAS ABLE TO BE RETRIEVED. IT WAS ALSO REPORTED THAT THE RELOAD WAS DIFFICULT TO LOAD AND THERE WAS DIFFICULTY ARTICULATING THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509802 ↗
• MalfunctionFeb 18, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PARASTOMAL HERNIA REPAIR SURGERY, WHEN SECURING THE MESH, WHEN THE HANDLE WAS SQUEEZED, TWO TACKS CAME OUT. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21401124 ↗
• MalfunctionFeb 11, 2025Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, THE TACKER WAS LOADED AND FIRED ONCE, HOWEVER THE SECOND TACK DID NOT FIRE AND GOT STUCK WHILE TACKING THE MESH TO FIXATE THE TISSUE. THE RELOAD CAME OFF THE HANDLE AND FELL INTO THE PATIENT CAVITY, WHERE IT WAS IMMEDIATELY RETRIEVED WITH LAPAROSCOPIC GRASPERS. A NEW TACKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360037 ↗
• MalfunctionOct 30, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE TIME OF MESH APPLICATION, THERE WERE DIFFICULTIES LOADING THE RELOAD ONTO THE HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20575075 ↗
• MalfunctionJul 22, 2024Positioning Failure; Device Difficult to Setup or Prepare; Difficult or Delayed Activation; Positioning Failure; Device Difficult to Setup or Prepare; Difficult or Delayed Activation

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL WALL SCAR HERNIA REPAIR, DURING MESH TACKING, TACKING WAS POSSIBLE, HOWEVER THE TACK STOPPED COMING OUT FROM MIDWAY, AND TACKING COULD NO LONGER BE DONE. EVEN UPON CHANGING THE CARTRIDGE, TACKING WAS STILL NOT POSSIBLE. IT WAS DIFFICULT TO LOAD THE RELOAD ONTO THE HANDLE AND DIFFICULT TO OPERATE THE LOCK AND UNLOCK BUTTON. A NEW DEVICE WAS TAKEN OUT AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19790665 ↗
• MalfunctionNov 30, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE, THE RELOAD WAS UNABLE TO BE LOADED INTO THE HANDLE. UPON R EMOVAL OF THE SHIPPING WEDGE, THE RELOAD WAS UNABLE TO BE SECURED ON THE HANDLE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243452 ↗
• MalfunctionJul 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE WHITE TIP OF THE DEVICE BROKE-OFF AND DEPLOYED INSIDE THE PATIENT. THEY WERE ABLE TO RETRIEVE THE PIECE IN THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299728 ↗
• MalfunctionMar 22, 2023Unintended Movement; Unintended Movement

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC VENTRAL HERNIA, WHEN THE SCRUB NURSE ASSEMBLED THE RELOADS, AND TESTED THE DEVICE, THE TIP OF THE DEVICE WAS NOT ABLE TO REMAIN FIXED WHEN ARTICULATED OR EVEN IN STRAIGHT POSITION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591853 ↗