TRAPLINER IPN913564Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841156100568), received between Aug 23, 2023 and Nov 7, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "THE TRAPLINER WAS ADVANCED TOO FAR EXPOSING THE COLLAR OUTSIDE OF THE GUIDE CATHETER. WHEN REALIZED PHYSICIAN ATTEMPTED TO CORRECT AND PULL BACK INTO THE GUIDE CATHETER CAUSING THE TRAPLINER TO BREAK INTO PIECES AT THE FLEX POINT WHILE CROSSING THE VD-OM. CATHETER WAS RETRIEVED SUCCESSFULLY WITH A GUIDELINER AND BALLOON AND PROCEDURE WAS COMPLETED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494576 ↗
• MalfunctionMay 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "UPON REMOVAL FROM THE HOOP, THE TRAPLINER WAS FOUND TO BE IN TWO SEPARATE PIECES. ANOTHER TRAPLINER WAS USED SUCCESSFULLY." THE ISSUE WAS IDENTIFIED PRIOR TO USE; THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992540 ↗
• MalfunctionApr 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: DURING A PROCEDURE, THE RT PREPPING THE TRAPLINER FLUSHED THE DEVICE. THE RT NOTED THAT THE TIP WAS SEPARATED. THE DEVICE WAS NEVER INSERTED INTO THE PATIENT. IT WAS SET ASIDE AND ANOTHER 8F TRAPLINER WAS PREPPED AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211327 ↗
• MalfunctionAug 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: A PIECE OF TRAPLINER BROKE OFF WHEN TECH WAS PREPPING IT. NOT USED ON A PATIENT. NO ADDITIONAL INFORMATION RECIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17601453 ↗