Passeo-18 2/150/150Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640130414716), received between Jul 24, 2019 and Nov 13, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (50% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE DISTAL ANTERIOR TIBIAL ARTERY. THE SYSTEM WAS PURGED AND INTRODUCED VIA A 6 F TERUMO INTRODUCER TO PERFORM ANGIOPLASTY OF THE ANTERIOR TIBIAL ARTERY. UPON INJECTION OF CONTRAST, IT WAS NOTED THAT THE BALLOON COULD NOT BE INFLATED. THE BALLOON WAS SUBSEQUENTLY WITHDRAWN, AND WHEN TESTED OUTSIDE THE PATIENT, CONTRAST LEAKAGE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541267 ↗
• MalfunctionOct 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90% STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID SFA. THE BALLOON COULD NOT REACH THE NBP WHEN INFLATE IN THE LESION. AFTER REMOVAL OF THE DEVICE, A BALLOON LEAKAGE WAS DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23263304 ↗
• MalfunctionNov 9, 2023Failure to Advance; Failure to Advance

  A PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A LESION WITH 87 PERCENT STENOSIS DEGREE IN A AVF. THE LESION COULD NOT BE CROSSED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102955 ↗
• MalfunctionMay 26, 2022Material Rupture; Material Rupture

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR PRE-DILATATION OF A LESION WITH 70 PERCENT STENOSIS DEGREE. AFTER THE BALLOON WAS ADVANCED TO THE LESION, THE BALLOON WAS INFLATED BUT RUPTURED AT 5 ATM. ANOTHER BALLOON WAS USED TO COMPLETE THE INTERVENTION. LOT NUMBER UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516148 ↗
• MalfunctionMay 20, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR PRE-DILATION OF A MODERATELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS SFA. UPON UNPACKING AND DELIVERING TO THE LESION THE BALLOON COULD NOT BE INFLATED AND LEAKAGE OF CONTRAST MEDIUM WAS NOTICED. FURTHERMORE, A PINHOLE WAS DETECTED. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462227 ↗
• MalfunctionAug 26, 2021Fracture; Fracture

  THE PHYSICIAN INTENDED TO TREAT A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE, VESSEL REFERENCE DIAMETER 6 MM, LESION LENGTH 180 MM) IN A MILDLY TORTUOUS BIFURCATION OF THE LEFT ANTERIOR TIBIAL ARTERY. A PASSEO-18 BALLOON CATHETER WAS USED FOR THE PROCEDURE. INITIALLY, IT WAS REPORTED THAT THE BALLOON OF THE COMPLAINT INSTRUMENT BURST AND RUPTURED IN THE VESSEL. AFTER ADDITIONAL CORRESPONDENCE WITH THE LOCAL STAFF IT WAS CLARIFIED THAT THE COMPLAINT INSTRUMENT WAS SUCCESSFULLY INFLATED THREE TIMES. AFTER BALLOON DEFLATION, THE INSTRUMENT WAS WITHDRAWN DURING WHICH THE BALLOON TORE OFF THE CATHETER. SINCE THE BALLOON COULD NOT BE RECOVERED, THE PATIENT UNDERWENT SURGERY. THE BALLOON WAS SUCCESSFULLY REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 12370304 ↗
• MalfunctionJul 24, 2019Inflation Problem; Inflation Problem

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON COULD NOT BE INFLATED DURING PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824073 ↗