TRAPLINER IPN913563Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841156100551), received between Mar 25, 2024 and Oct 10, 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 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.

• MalfunctionOct 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "PRODUCT SEPARATED INTO 2 PIECES. IT BROKE ENTERING INTO THE HEMOSTASIS VALVE. NO AIR, PARTICULATE OR COMPONENT WAS REPORTED ENTERING THE VASCULATURE. NO HARM, INJURY OR CONSEQUENCE WAS REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23264420 ↗
• MalfunctionAug 22, 2024Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED "TRAPLINER WAS BEING USED DURING A CASE, WHEN INSERTING FURTHER INSTRUMENTS THE TRAPLINER BROKE AT THE ACCESS POINT ABOVE THE HALF PIPE." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL QUESTIONS HAVE BEEN REQUESTED FROM THE CUSTOMER, HOWEVER NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20035848 ↗
• MalfunctionMar 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "THE SCRUB TECH, SAID THE DEVICE BROKE INTO 2 PIECES. NO MORE INFORMATION WAS PROVIDED." ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984943 ↗
• MalfunctionMar 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "THE BALLOON SECTION BENT & SEPARATED WHILE LOADING INTO THE GUIDE CATHETER. TRAP LINER BUCKLED & SEPARATION OCCURRED AFTER MINIMAL FORCE WAS APPLIED TO ADVANCE. TRAP LINER WAS REMOVED & A SECOND TRAP LINER WAS INSERTED & USED." ADDITIONAL INFORMATION: THE ISSUE OCCURRED PRIOR TO USE ON THE PATIENT. THE TRAPLINER BROKE MID BALLOON. THE TRAPLINER WAS REMOVED FROM GUIDE CATH --NEW ONE OPENED AND USED WITHOUT ISSUE. THERE WAS NO EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967966 ↗