Passeo-18 4/150/130Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07640130414754), received between Apr 23, 2019 and Mar 25, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Material Deformation

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (80% STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE FEMORAL ARTERY. DURING CATHETER ADVANCEMENT, THE DISTAL END OF THE BALLOON WAS DAMAGED AND DEFORMED, PREVENTING IT FROM INFLATION AND EXPANSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684505 ↗
• MalfunctionMay 7, 2024Material Rupture; Material Rupture

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (75 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID SFA. THE AFFECTED DEVICE WAS POSITIONED IN THE TARGET LESION AND INFLATED BUT THE BALLOON BURST. THE AFFECTED DEVICE WAS WITHDRAWN, AND A STENT SYSTEM WAS USED TO FINISH THE INTERVENTION. AFTER ADDITIONAL CORRESPONDENCE WITH THE LOCAL STAFF, IT WAS CONFIRMED THAT THE PATIENT HAD BLOOD-BORNE DISEASE DUE TO WHICH THE AFFECTED DEVICE HAD BEEN DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264591 ↗
• MalfunctionOct 25, 2023Failure to Advance; Failure to Advance

  A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS PART OF THE FEMORAL ARTERY. THE LESION COULD NOT BE PASSED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004167 ↗
• MalfunctionSep 19, 2023Inflation Problem; Inflation Problem

  A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A 150MM LONG LESION WITH 80 PERCENT STENOSIS DEGREE. AFTER PRE-DILATATION WITH A SMALLER BALLOON, THE DEVICE WAS INTRODUCED, BUT THE BALLOON COULD NOT BE INFLATED. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777662 ↗
• MalfunctionMay 15, 2023Failure to Advance; Failure to Advance

  THE PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR PRE-DILATATION OF A MODERATELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS RIGHT SFA, BUT THE DEVICE COULD NOT PASS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936583 ↗
• MalfunctionJun 2, 2022Fracture; Fracture

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR PRE-DILATATION OF A MODERATELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS SFA. DURING INFLATION IT WAS NOTICED THAT NO PRESSURE COULD BE BUILD UP AND THE BALLOON HAS BEEN RUPTURED. UPON REMOVAL, A PART OF THE BALLOON REMAINED INSIDE THE VESSEL BUT WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14579526 ↗
• MalfunctionJul 1, 2020Inflation Problem; Inflation Problem

  THE PASSEO-18 BALLOON COULD NOT BE INFLATED MORE THAN 2-3 ATM. AFTER WITHDRAWAL IT WAS NOTED THAT THE INSIDE OF THE BALLOON WAS FULL OF BLOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10219926 ↗
• MalfunctionMay 6, 2020Material Rupture; Material Rupture

  A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE SFA. AT 10 BAR PRESSURE, THE BALLOON RUPTURED IN THE MID TO DISTAL SFA AND HAD TO BE REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10030980 ↗
• MalfunctionApr 23, 2019Material Puncture/Hole; Material Puncture/Hole

  OUS MDR - AS IT WAS ATTEMPTED TO PLACE THE PASSEO-18 BALLOON CATHETER INSIDE THE LESION IT WAS NOTICED THAT FLUID WAS EXITING FROM THE HUB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8540409 ↗