ReliaTack RELTACK8RDPTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521202372), received between Aug 26, 2017 and Mar 16, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN FIXING THE MESH DURING LAPAROSCOPIC ABDOMINAL WALL HERNIA PROCEDURE, AFTER FIRING, THE TACK FELL INTO THE PATIENT¿S ABDOMINAL CAVITY. IT WAS VISUALLY NOTED AND COLLECTED, AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494549 ↗
• MalfunctionFeb 12, 2020Positioning Failure; Positioning Failure

  ACCORDING TO THE REPORTER, AT THE FIFTH FIRING DURING ABDOMINAL WALL HERNIA REPAIR, FIRING WAS UNABLE TO BE PERFORMED AT THE MIDDLE OF TACKING, AND FIRING WAS ALSO UNSUCCESSFUL EVEN AFTER REPLACING THE CARTRIDGE. SEVERAL CARTRIDGES WERE REPLACED, BUT THE RESULT WAS THE SAME, SO THE DEVICE WAS UNABLE TO BE USED. THE PROCEDURE WAS COMPLETED WITH MANUAL SUTURING. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9702516 ↗
• MalfunctionMar 27, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL PROCEDURE, THE DEVICES DISENGAGED INTO THE CAVITY OF THE PATIENT. RELOAD FELL INTO THE PATIENT WHILE TACKING THE MESH IN PLACE. RELOAD WAS TAKEN OUT IN ORDER TO COMPLETE THE CASE. THERE WAS NO INJURY TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7374170 ↗
• MalfunctionAug 26, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  ACCORDING TO THE REPORTER, WHILE TACKING IN MESH DURING THE LAPAROSCOPIC UMBILICAL HERNIA PROCEDURE, THE DEVICE WAS NOT ABLE TO PENETRATE AND HOLD CORRECTLY ONTO THE TISSUE OF THE PATIENT. THEY OPENED ANOTHER TACKER TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6823086 ↗