ReliaTack RELTACK5RDPTRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20884521202402), received between Feb 22, 2018 and Feb 27, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionJul 30, 2025Device Difficult to Setup or Prepare; Insufficient Device Problem Information; Device Difficult to Setup or Prepare; Insufficient Device Problem Information

  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 22666278 ↗
• MalfunctionJul 30, 2025Device Difficult to Setup or Prepare; Insufficient Device Problem Information; Device Difficult to Setup or Prepare; Insufficient Device Problem Information

  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 22666050 ↗
• MalfunctionMar 25, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING ABDOMINAL WALL HERNIA, AT THE 3RD FIRING, RELEASE COULD NOT BE PERFORMED NORMALLY. THE DEVICE WAS REMOVED FROM THE TISSUE BY FORCE BUT NO TISSUE DAMAGE WAS CAUSED. BOTH OF THE TWO DEVICE'S HANDLE SQUEEZING WERE NOT FULL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8449031 ↗
• MalfunctionDec 13, 2018Loss of or Failure to Bond; Noise, Audible; Loss of or Failure to Bond; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A ABDOMINAL WALL HERNIA, THE RELOAD INSIDE THE PACKAGE WITH 8 TACKS WAS LOADED AND FIRED, BUT THE HANDLE GENERATED A STRANGE CRACKLING SOUND WHEN SQUEEZED, AND 1/4 DEPTH OF THE TACK DID NOT GO INTO THE TISSUE, AND IT WAS FIXED INA STATUS LIKE FLOATING. THE SECOND TACK COULD BE TACKED INTO THE TISSUE WELL, BUT IN THE FOLLOWING FIRINGS, THE EVENT OCCURRED SEVERAL TIMES THAT 1/4 TACK DID NOT GO INTO THE TISSUE. OOZING BLEEDING OCCURRED AS A RESULT OF THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8160382 ↗
• MalfunctionJun 28, 2018Detachment Of Device Component; Mechanics Altered; Detachment Of Device Component; Mechanics Altered

  ACCORDING TO THE REPORTER,DURING AN ABDOMINAL WALL HERNIA PROCEDURE, THE FIRST CARTRIDGE WAS LOADED WITHOUT INCIDENT. THE DEVICE MADE A STRANGE NOISE DURING FIRING. AMONG 29 TACKS FROM THE ATTACHED CARTRIDGE AND 25 TACKS FROM THE ADDITIONAL RELOAD HAD BEEN FIRED, ABOUT 15 TACKS WERE MISFIRED. THE HANDLE WAS REPLACED WITH NEW ONE AND THE NEW ONE WORKED FINE. A PART OF THE DEVICE FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7645513 ↗
• MalfunctionFeb 22, 2018Positioning Failure; Device Difficult to Setup or Prepare; Positioning Problem; Positioning Failure; Device Difficult to Setup or Prepare; Positioning Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRA-PERITONEAL INGUINAL PROCEDURE, WHILE ON THE LAST STEP OF TACKING IN THE MESH TO SECURE REPAIR, THERE WAS DIFFICULTY IN PRESSING THE "PUSH TO RELOAD" BUTTON BUT NAVIGATING THE LOCK AND UNLOCK BUTTON WAS FINE. THERE WAS ALSO DIFFICULTY ARTICULATING THE DEVICE. THE DEVICE JAMMED AND WOULD NOT FIRE. THEY TRIED TO CHANGE RELOAD AND THAT WOULD NOT LOAD AND FIRE. NO TACKS WERE ABLE TO BE FIRED FROM THE DEVICE. THEY HAD TO OPEN AN ENTIRELY NEW BOX OF THE PRODUCT AND THAT NEW DEVICE PERFORMED AS EXPECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7288710 ↗