Tacker OMS-TTSDRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521070486), received between Mar 5, 2020 and Dec 29, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K090470); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2023Loss of or Failure to Bond; Positioning Failure; Loss of or Failure to Bond; Positioning Failure

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROMONTOFIXATION PROCEDURE, AT THE TIME OF FIXATING THE MESH, THE HANDLE COULD NOT BE SQUEEZED AFTER ONE TACK WAS ABLE TO PENETRATE THE TISSUE. THE ISSUE OCCURRED IN TWO TACKING DEVICES EXCEPT THAT THE SECOND IS SLIGHTLY ATTACHED TO THE MESH AND IN THE PLIERS; IT DID NOT PENETRATE THE TISSUE. DUE TO THE ISSUE, THE MESH WAS DAMAGED. THE SURGEON USED TWO TACKERS AND SUTURED THE DAMAGE ON THE MESH TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18416746 ↗
• MalfunctionMar 6, 2023Mechanical Jam; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROLAPSE PROCEDURE, FIXATION OF THE MESH, THE SURGEON WAS ABLE TO USE THE SPRING, THEN THE TWO DEVICES JAMMED WITH THE SAME LOT NUMBER. A THIRD DEVICE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491906 ↗
• InjuryMar 5, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED ADHESIONS, PAIN, WOUND DEHISCENCE, ASCITES, MESH DIVIDED, TACK LOOSE IN TISSUE, AND MESH FAILURE. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, REMOVAL OF MESH AND MANY PROTACKS, IMPLANTATION OF NEW MESH, AND CLOSURE DEHISCENCE.

  Patient problems: Adhesion(s); Ascites; Injury; Pain; Wound Dehiscence

  MAUDE report 9791321 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090470. One submission often covers many models, so check the product and lot details in each record.

• Z-0986-2024 · Nov 16, 2023 · Open, Classified
  AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia
• Z-1157-2010 · Feb 8, 2010 · Terminated
  Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures.