Passeo-35 5/40/130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640119558394), received between Aug 24, 2021 and Sep 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT. DURING ATTEMPT TO DILATE AN ARTERIOVENOUS FISTULA, THE BALLOON COULD NOT BE INFLATED, AND A LEAKAGE WAS DETECTED. THE DEVICE WAS WITHDRAWN, AND ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755392 ↗
• MalfunctionAug 24, 2021Material Rupture; Material Rupture

  A PASSEO-35 BALLOON WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS MID FEMORAL ARTERY. AFTER DILATATION WITH A 4.0/40 BALLOON, THE COMPLAINT BALLOON WAS USED FOR ADDITIONAL DILATATION BUT AT 10 ATM THE PRESSURE SUDDENLY DROPPED TO 0. AFTER WITHDRAWAL IT WAS DETECTED THAT THERE WAS A HOLE AT THE END OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359706 ↗