TK® Ti-KNOT® 030404Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850200006094), received between Sep 3, 2019 and Sep 13, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 13, 2024

  THE TI-KNOTS WERE FOUND TO BE NOT SITTING CORRECTLY ON THE DEVICE. THIS DEVICE WAS REMOVED FROM THE SURGICAL AREA AND ANOTHER DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211650 ↗
• MalfunctionSep 4, 2019Fitting Problem

  DURING PROCEDURE, SURGEON COULD NOT LOAD THE TK TI-KNOT NEEDLE INTO THE HANDLE. SURGEON SAID THAT THE HOLE WAS TOO SMALL FOR THE DEVICE TO FIT. THE SYSTEM WOULD NOT ALLOW THE NEEDLE TO LOAD INTO IT. 2 DIFFERENT NEEDLES WERE TRIED WITHOUT SUCCESS. ANOTHER HANDLE WAS OPENED AND USED WITHOUT ANY ISSUE LOADING NEEDLES. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8960567 ↗
• MalfunctionSep 4, 2019Difficult to Open or Close

  AS OPERATING ROOM STAFF WERE SETTING UP FOR A SURGICAL CASE, THEY TRIED OPENING THE LSI SOLUTIONS TK TI-KNOT (REF 030404, LOT # 739987) DEVICE PACKAGING BUT IT WOULDN'T OPEN PROPERLY. THE PACKAGING WOULDN'T PEEL OPEN AS IT NORMALLY WOULD, BUT RATHER THE PAPER COVER WAS PEELING IN HALF. SINCE THE STAFF COULDN'T GUARANTEE THE STERILITY OF THE CONTENTS OF THE PACKAGE/DEVICE, THEY COULDN'T USE THE DEVICE AND HAD TO OPEN A SECOND DEVICE FOR THE CASE.

  Patient problems: No Patient Involvement

  MAUDE report 8960536 ↗
• MalfunctionSep 3, 2019Difficult to Open or Close

  AS THE OR STAFF WERE SETTING UP FOR A BARIATRIC CASE, THEY TRIED OPENING THE LSI SOLUTIONS TK TIKNOT (REF: (B)(4) DEVICE PACKAGING BUT IT WOULDN'T OPEN PROPERLY. THE PACKAGING WOULDN'T PEEL OPEN AS IT NORMALLY WOULD, BUT RATHER THE PAPER COVER WAS PEELING IN HALF. SINCE THE STAFF COULDN'T GUARANTEE THE STERILITY OF THE CONTENTS OF THE PACKAGE/DEVICE, THEY COULDN'T USE THE DEVICE AND HAD TO OPEN A SECOND DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 8955423 ↗
• MalfunctionSep 3, 2019Packaging Problem

  AS THE OPERATING ROOM STAFF WERE SETTING UP FOR A BARIATRIC CASE, THEY TRIED OPENING THE SECOND LSI SOLUTIONS TK TI-KNOT DEVICE (REF (B)(4)) PACKAGING BUT IT WOULDN'T OPEN PROPERLY. THE PACKAGING WOULDN'T PEEL OPEN AS IT NORMALLY WOULD, BUT RATHER THE PAPER COVER WAS PEELING IN HALF. SINCE THE STAFF COULDN'T GUARANTEE THE STERILITY OF THE CONTENTS OF THE PACKAGE/DEVICE, THEY COULDN'T USE THE DEVICE AND HAD TO OPEN A THIRD DEVICE WHICH OPENED WITHOUT DIFFICULTY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8955387 ↗