Passeo-18 5/60/130Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640119559100), received between Jan 6, 2020 and Jul 20, 2023 — classified as 2 malfunctions.

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

• MalfunctionJul 20, 2023Material Puncture/Hole; Mechanical Jam; Material Puncture/Hole; Mechanical Jam

  A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN A SEGMENT OF THE DISTAL SFA / P1 SEGMENT. BY USE OF A 6F INTRODUCER SHEATH AND A 0.018 INCH GUIDEWIRE THE COMPLAINT INSTRUMENT WAS ADVANCED TOWARDS THE TARGET LESION, BUT NEITHER THE GUIDEWIRE NOR THE COMPLAINT INSTRUMENT WAS ABLE TO CROSS THE TARGET LESION. THE BALLOON COULD THEN NO LONGER BE PUSHED OVER WIRE, LIKE IT WAS GLUED, AND BOTH DEVICES COULD ONLY BE REMOVED TOGETHER. FURTHER, IN THE CATHLAB REPORT IT IS MENTIONED THAT THE BALLOON OF THE COMPLAINT INSTRUMENT BURST DURING THE FIRST INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17363924 ↗
• MalfunctionJan 6, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PASSEO-18 BALLOON CATHETER WAS SELECTED FOR THE TREATMENT OF A SEVERE CALCIFIED LESION IN THE MID SFA. WHEN INFLATING THE BALLOON, THE BALLOON COULD NOT HOLD PRESSURE. THE PHYSICIAN HAD THE IMPRESSION THAT THERE IS A HOLE IN THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9553177 ↗