ReliaTack RELTACK5RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884521202419), received between Dec 15, 2017 and Mar 29, 2018 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2018Failure To Adhere Or Bond; Positioning Problem; Failure To Adhere Or Bond; Positioning Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, WHILE ATTEMPTING TO FIXATE THE MES TO THE BONY PROMINENCE, THE FIRST DEVICE WITH THE RELOAD DID NOT PENETRATE THE BONE AS DESIRED. THE SECOND DEVICE WITH SECOND RELOAD WAS USED BUT THE SURGEON WAS NOT SATISFIED WITH THE FIXATION TO THE BONE AND SURGEON WAS AWARE OF SOME BLEEDING AT THE SITE ON THE SECOND APPLICATION. SURGEON USED A THIRD DEVICE WHICH IS DIFFERENT NOW THE INITIAL DEVICES THAT WAS USED, IT WAS APPLIED TO THE SAME SURGICAL SITE AND THE SURGEON WAS SATISFIED WITH THE FIXATION ACHIEVED. THE PROCEDURE WAS COMPLETED USING THE THIRD INSTRUMENT. THE FEEDBACK WAS THAT THE FIRST TWO INSTRUMENT WERE NOT ARTICULATED DURING THE FIRST TWO APPLICATIONS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7382926 ↗
• MalfunctionMar 29, 2018Failure To Adhere Or Bond; Positioning Problem; Failure To Adhere Or Bond; Positioning Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, WHILE ATTEMPTING TO FIXATE THE MES TO THE BONY PROMINENCE, THE FIRST DEVICE WITH THE RELOAD DID NOT PENETRATE THE BONE AS DESIRED. THE SECOND DEVICE WITH SECOND RELOAD WAS USED BUT THE SURGEON WAS NOT SATISFIED WITH THE FIXATION TO THE BONE AND SURGEON WAS AWARE OF SOME BLEEDING AT THE SITE ON THE SECOND APPLICATION. SURGEON USED A THIRD DEVICE WHICH IS DIFFERENT NOW THE INITIAL DEVICES THAT WAS USED, IT WAS APPLIED TO THE SAME SURGICAL SITE AND THE SURGEON WAS SATISFIED WITH THE FIXATION ACHIEVED. THE PROCEDURE WAS COMPLETED USING THE THIRD INSTRUMENT. THE FEEDBACK WAS THAT THE FIRST TWO INSTRUMENT WERE NOT ARTICULATED DURING THE FIRST TWO APPLICATIONS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7382836 ↗
• InjuryFeb 28, 2018Failure To Adhere Or Bond; Detachment Of Device Component; Failure To Adhere Or Bond; Detachment Of Device Component

  ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH REPAIR (IPOM) PROCEDURE. THE RELOADABLE TACKING DEVICES WERE USED TO TACK THE MESH TO THE ABDOMINAL WALL. A SECOND OPERATION WAS REQUIRED SIX DAYS AFTER THE ORIGINAL PROCEDURE. THERE WAS INJURY AS A RESULT OF THE EVENT, TACKS WERE IN THE CAVITY OF THE PATIENT. TWELVE TACKS FELL INTO THE CAVITY OF THE PATIENT. THERE MAY BE MORE TACKS. THE PATIENT OUTCOME IS REPORTED HAS NO INJURY.

  Patient problems: Injury; No Code Available

  MAUDE report 7302917 ↗
• MalfunctionDec 19, 2017Difficult or Delayed Positioning; Device Difficult to Setup or Prepare; Mechanics Altered; Difficult or Delayed Positioning; Device Difficult to Setup or Prepare; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, WHILE FIXATING THE MESH, THERE WERE DIFFICULTIES WITH LOADING THE RELOAD ONTO THE HANDLE ALTHOUGH THE RELOAD SECURELY FASTENED ONTO THE SHAFT. THE RELOADS WERE NOT ABLE TO LOAD PROPERLY DUE TO MISALIGNMENT OF THE RELOAD AND THE FLAT HEAD TIP OF DEVICE HANDLE. SOME TACKS COULD NOT BE FIRED, AND WERE ONLY ABLE TO BE FIRED AFTER SOME DIFFICULTY. TO RESOLVE THE ISSUE, MORE TACKS WERE OPENED BUT SOME TACKS WERE NOT ABLE TO FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7129716 ↗
• MalfunctionDec 15, 2017Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE DEVICE WAS JAMMED ON FIRST FIRING. THERE WERE DIFFICULTIES WITH LOADING THE RELOAD ONTO THE HANDLE, PRESSING THE 'PUSH TO RELOAD' BUTTON AND NAVIGATING THE LOCK AND UNLOCK BUTTON. ANOTHER DEVICE WAS OPENED WITH THE SAME LOT NUMBER AND WAS USED SUCCESSFULLY. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7123818 ↗