Fast-Cath™ 406153Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734014274), received between Feb 4, 2022 and Feb 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2022Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  DURING THE PROCEDURE, THE INTRODUCER WAS INSERTED INTO THE PATIENT BUT RESISTANCE WAS NOTED. THE DEVICE WAS WITHDRAWN AND THE DEVICE WAS NOTED TO BE KINKED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE WITH NO ADVERSE PATIENT CONSEQUENCES. DUE TO HAVING TO EXCHANGE THE INTRODUCER, A SECOND FEMORAL ACCESS SITE HAD TO BE CREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13479660 ↗
• MalfunctionFeb 4, 2022Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  DURING THE PROCEDURE, THE INTRODUCER WAS INSERTED INTO THE PATIENT BUT RESISTANCE WAS NOTED. UPON WITHDRAWAL, THE DEVICE WAS NOTED TO BE KINKED. AN ADDITIONAL FEMORAL PUNCTURE SITE/ACCESS WAS REQUIRED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13450703 ↗