TRAPLINER IPN913562Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841156100544), received between Mar 26, 2020 and Jul 16, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "TRAPLINER WAS INSERTED AS USUAL. UPON FIRST DEVICE EXCHANGE, THE BALLOON WAS UNABLE TO ENTER THE EXTENSION PORTION, AND THE ENTIRE SYSTEM WAS REMOVED. THERE WAS A COLLAR SEPARATION, THE HYPOTUBE DID NOT VISUALLY APPEAR DAMAGED. IT WAS UNCLEAR WHETHER THE COLLAR SEPARATED DURING THE EXCHANGE OR IF IT HAD BEEN DAMAGED BEFORE USE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518683 ↗
• MalfunctionMar 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "THE TECH SAID THAT THE HALF PIPE BROKE INTO 2 PIECES SEPARATED INSIDE THE GUIDE CATHETER. THEY HAD TO PULL EVERYTHING OUT , IT WAS TRAPPED WITH A BALLOON AND PULLED OUT ALONG WITH THE GUIDE CATHETER. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION NEEDED DUE TO PRODUCT AND NO REPORTED PATIENT HARM. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984970 ↗
• MalfunctionMar 26, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PHYSICIAN WAS PUSHING THE GUIDE EXTENSION OF THE TRAPLINER THROUGH THE CO-PILOT AND IT SNAPPED BEFORE ENTERING THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9883531 ↗