Tacker OMS-TTSD30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521070493), received between Jul 10, 2023 and Feb 20, 2024 — classified as 3 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.

• MalfunctionFeb 20, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROMONTOFIXATION, DURING MESH FIXATION, WHEN THE SURGEON FIRED, TWO TACKS TANGLED CAME OUT AT THE SAME TIME, THEN IT WAS IMPOSSIBLE TO FIRE A NEW TACK SINCE THE HANDLE WAS BLOCKED. A NEW TACKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744140 ↗
• MalfunctionJul 10, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING HERNIA REPAIR, THE SURGEON TRIED TO FIX MESH USING TACKER WITHOUT SUCCESS. ANOTHER TRACKER WAS USED WITH SAME ISSUE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17293836 ↗
• MalfunctionJul 10, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING HERNIA REPAIR, THE SURGEON TRIED TO FIX THE MESH USING THE TACKER WITHOUT SUCCESS. ANOTHER TRACKER WAS USED WITH SAME ISSUE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17293815 ↗

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.