Passeo-18 2.5/150/130Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640130414723), received between Jul 1, 2021 and Sep 23, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION WITH 70% STENOSIS DEGREE. THE DEVICE WAS DELIVERED TO THE LESION BUT COULD NOT BE INFLATED. IT WAS NOTICED AFTER WITHDRAWAL THAT THE BALLOON WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23119634 ↗
• MalfunctionJun 18, 2024Fracture; Difficult to Remove; Material Deformation; Fracture; Difficult to Remove; Material Deformation

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE SEVERELY TORTUOUS MID PART OF THE SFA. AFTER DILATATION, THE DEVICE COULD NOT BE WITHDRAWN OVER THE V18 GUIDE WIRE. THE ENTIRE SYSTEM WAS REMOVED, AND ANOTHER DEVICE WAS USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19557066 ↗
• MalfunctionJul 11, 2023Material Rupture; Material Rupture

  THE PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. IT WAS ATTEMPTED TO PRE-DILATE A MODERATELY CALCIFIED LESION WITH 90 PERCENT STENOSIS DEGREE IN THE RIGHT SFA. THE PASSEO-18 WAS ADVANCED TO THE LESION BUT COULD NOT FURTHER BE INFLATED WHEN THE PRESSURE REACHED 3 ATM. TWO OTHER PASSEO-18 BALLOONS WERE USED AFTERWARDS, BUT BOTH ALSO RUPTURED (FILED SEPARATELY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298505 ↗
• MalfunctionJul 11, 2023Material Rupture; Material Rupture

  THE PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. IT WAS ATTEMPTED TO PRE-DILATE A MODERATELY CALCIFIED LESION WITH 90 PERCENT STENOSIS DEGREE IN THE RIGHT SFA. TWO PASSEO-18 WAS ADVANCED TO THE LESION BUT COULD NOT FURTHER BE INFLATED WHEN THE PRESSURE REACHED 3 ATM (REPORTED SEPARATELY). THE 3RD PASSEO-18 BALLOON (COMPLAINT DEVICE) WAS USED AFTERWARDS, BUT ALSO RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298488 ↗
• MalfunctionJun 27, 2023Failure to Advance; Failure to Advance

  THE PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT, BUT THE LESION COULD NOT BE CROSSED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17214028 ↗
• MalfunctionDec 14, 2021Material Puncture/Hole; Material Puncture/Hole

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT A MODERATELY CALCIFIED LESION. AFTER PASSING THE V-18 GUIDEWIRE THROUGH THE LESION TO THE DISTAL END OF THE ANTERIOR TIBIAL ARTERY, A SERIOUS STENOSIS OF ABOUT 30MM WAS DETECTED. THE PASSEO-18 WAS INTRODUCED AND INFLATED UP TO 10BAR. HOWEVER, THE IMAGES SHOWED A LEAKAGE OF CONTRAST MEDIUM AND UPON WITHDRAWAL OF THE BALLOON, A PINHOLE WAS DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003101 ↗
• MalfunctionJul 1, 2021Difficult to Remove; Difficult to Remove

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MILDLY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS POSTERIOR TIBIAL ARTERY. AFTER INFLATION THE BALLOON COULD NOT BE REMOVED. THE BALLOON WAS STUCK WITH THE WIRE AND THE WIRE COULD NOT BE REMOVE FROM THE BALLOON. THUS, THE WHOLE SYSTEM (BALLOON WITH WIRE) WERE REMOVED TOGETHER FROM THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099145 ↗