ReliaTackRecalls & reported problems across all models

We found 10 models of ReliaTack by Covidien LP in the FDA's device registry (GUDID). Together they are named in 391 adverse event reports in the FDA's MAUDE database, received between Jan 31, 2017 and Aug 27, 2026 — classified as 27 injuries, 364 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (175 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ReliaTack problems

ReliaTack models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ReliaTack RELTACK3X10

  STAPLE, IMPLANTABLE
  179 reports
• ReliaTack RELTACK4XDPT

  STAPLE, IMPLANTABLE
  113 reports
• ReliaTack RELTACK4xDPTSW

  STAPLE, IMPLANTABLE
  50 reports
• ReliaTack RELTACK3X10SW

  STAPLE, IMPLANTABLE
  23 reports
• ReliaTack RELTACK5RDPT

  STAPLE, IMPLANTABLE
  8 reports
• ReliaTack RELTACK10R

  STAPLE, IMPLANTABLE
  6 reports
• ReliaTack RELTACK5R

  STAPLE, IMPLANTABLE
  5 reports
• ReliaTack RELTACK8RDPT

  STAPLE, IMPLANTABLE
  4 reports
• ReliaTack RELTACK8RDPTSW

  STAPLE, IMPLANTABLE
  2 reports
• ReliaTack RELTACK5RSW

  STAPLE, IMPLANTABLE
  1 report

Recent ReliaTack adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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, 2026Noise, Audible; Separation 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 24476433 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 26, 2025Failure to Advance; Failure to Advance

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL WALL INCISIONAL HERNIA REPAIR, AFTER REPLACING THE CARTRIDGE, THE FIRST F IRING RESULTED IN THE TACK NOT FULLY DEPLOYING AND THE CARTRIDGE TIP FAILING TO DETACH FROM THE TACK DESPITE FULLY SQUEEZING THE HANDLE, A SECOND SQUEEZE RELEASED IT, BUT THE NEXT TACK AGAIN DEPLOYED ONLY PARTIALLY. A THIRD FIRING WAS ATTEMPTED OUTSIDE THE PATIENT¿S BODY, AND THE TACK STILL DID NOT FULLY DEPLOY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23897810 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall