TracStar LDP Large Distal Platform ICAC088095Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812212030337), received between Jun 30, 2022 and Jun 30, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2022Break; Material Separation; Break; Material Separation

  THE PATIENT WAS UNDERGOING A VENOUS STENTING CASE. UPON COMPLETION OF THE CASE AND DURING RETRACTION, THE DISTAL PORTION OF THE TRACSTAR GOT CAUGHT ON THE PREVIOUSLY DEPLOYED STENT AND BROKE SEVERAL CENTIMETERS FROM THE DISTAL END OF THE CATHETER IN THE INTERNAL JUGULAR. THE PATIENT REPORTEDLY HAD A VERY ZIG-ZAG TORTUOUS ANATOMY. THE DISTAL PORTION OF THE CATHETER WAS RETRIEVED WITH A SNARE. PATIENT WAS REPORTED TO BE DOING FINE AND NO COMPLICATIONS WERE REPORTED. THE PHYSICIAN DID NOT REPORT ANY ISSUES WITH THE TRACSTAR. DURING FOLLOW-UP, THE PHYSICIAN INFORMED THAT THE SHORT SHEATH WAS IN THE "Z" OR ZIG-ZAG SHAPE IN THE BODY AS A FACTOR FOR THE TRACSTAR SHAFT BEING BROKEN. THE RETRACTION WAS HARDER THAN NORMAL BASED ON HAVING TO PULL THROUGH THIS TORTUOUS "Z".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877123 ↗