ReliaTack RELTACK10RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20884521202389), received between Nov 16, 2017 and Feb 28, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Component or Accessory Incompatibility” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2022Difficult to Remove; Component or Accessory Incompatibility; Difficult to Remove; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE NURSE HAD A PROBLEM REMOVING THE YELLOW SAFETY TAGGING ON THE RELOAD. THERE WAS ALSO A DIFFICULTY LOADING THE RELOAD INTO THE HANDLE AND WAS NOT USED IN THE PATIENT. TO RESOLVE THE ISSUE, A NEW RELOAD WAS USED. THE OPERATION WAS PROLONGED FOR MORE THAN THIRTY MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13618752 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD INTRAPERITONEAL MESH IMPLANTED AND DAYS LATER THAT NEEDED TO BE RE-OPERATED FOR INTESTINAL PERFORATION. IT WAS VERIFIED THAT THE STAPLES PRODUCED A RELIEF (PROMINENCE PROTRUSION) ON THE SURFACE OF THE INTRA-ABDOMINAL WALL TO WHICH THE INTESTINAL LOOPS ADHERE, AND DECUBITUS MIGHT OCCUR AT THAT LEVEL.

  Patient problems: Bowel Perforation

  MAUDE report 12949694 ↗
• MalfunctionOct 17, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, WHEN FIXING THE MESH INTO THE ABDOMINAL CAVITY TO COVER THE HERNIA DEFECT DURING A LAPAROSCOPIC UMBILICAL HERNIA REPAIR, THE TACKS DID NOT PENETRATE THE MESH PROPERLY AND DID NOT STAY IN PLACE AND EMERGED FROM THE MESH. THE SURGEON HAD TO REMOVE ALL THE TACKS AND USED ANOTHER RELOAD TO COMPLETE THE FIXATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203962 ↗
• InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER POST OPERATIVE A LAPAROSCOPIC INCISIONAL HERNIA REPAIR THE DEVICE HAD UNKNOWN MALFUNCTION. THE PATIENT IS DECEASED DUE TO PULMONARY EMBOLISM AS A RESULT OF DVT (DEEP VEIN THROMBOSIS) WHICH IS NOT DEVICE RELATED.

  Patient problems: Death

  MAUDE report 9177695 ↗
• 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. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, USED A DIFFERENT MANUFACTURERS TACKING DEVICE. THE PATIENT OUTCOME IS REPORTED AS WITH INJURY.

  Patient problems: Injury; No Code Available

  MAUDE report 7302911 ↗
• MalfunctionNov 16, 2017Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, THERE WAS DIFFICULTY EXPERIENCED IN LOADING THE RELOAD ONTO THE DEVICE AND THE RELOAD WAS NOT SECURELY FASTENED ONTO THE SHAFT. THE TACKER WAS ABLE TO BE FIRED NORMALLY BUT A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE DEVICE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7039385 ↗