Passeo-18 3/200/130Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640130430051), received between Jan 5, 2022 and Dec 16, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Material Rupture; Material Rupture

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (85% STENOSIS DEGREE) IN A SEVERELY TORTUOUS PART OF THE MID SFA. DURING INFLATION OF THE DEVICE THE BALLOON RUPTURED. THE DEVICE WAS WITHDRAWN AND NO PART REMAINS IN BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23814394 ↗
• MalfunctionJul 23, 2025Failure to Advance; Failure to Advance

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL SUBCLAVIAN ARTERY. AN ACCESS WAS MADE WITH A 5F INTRODUCER SHEATH THROUGH THE RIGHT FEMORAL ARTERY. A FIRST ATTEMPT WAS MADE TO CROSS THE LESION WITH A GUIDE WIRE BUT WAS UNSUCCESSFUL. THE GUIDEWIRE WAS CHANGED TO A 0.018" GUIDE WIRE TOGETHER WITH A "SINGLE BEND" SUPPORTING CATHETER BUT THE TARGET LESION COULD NOT BE CROSSED. FOLLOWING, THE COMPLAINT DEVICE WAS INSERTED OVER THE 0.018" GUIDE WIRE. AN INITIAL ATTEMPT TO CROSS THE TARGET LESION IN THE SUBCLAVIAN ARTERY FAILED. AFTER "REPEATED MANEUVERS" (NO FURTHER INFORMATION ABOUT THE MANEUVERS OR DEVICES USED WERE GIVEN) IT WAS POSSIBLE TO CROSS THE LESION WITH THE GUIDE WIRE. THE COMPLAINT DEVICE WAS THEN ADVANCED IN STEPS OVER THE TARGET LESION AND THE TARGET LESION WAS "DILATED SLOWLY" UNTIL A FLOW WAS ESTABLISHED IN THE DISTAL SUBCLAVIAN ARTERY. THEREAFTER, THE COMPLAINT DEVICE WAS WITHDRAWN. THE SUBCLAVIAN ARTERY WAS FURTHER DILATED BY DIFFERENT OTHER BALLOON CATHETERS. AFTER THESE BALLOONS AN ADDITIONAL DRUG ELUTING STENT WAS IMPLANTED IN THE SUBCLAVIAN ARTERY AND THE FLOW WAS FUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574650 ↗
• MalfunctionFeb 4, 2025Failure to Advance; Failure to Advance

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (85 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF THE OSTIAL TO PROXIMAL RIGHT SFA. THE LESION WAS ACCESSED WITH A 6F MERIT INTRODUCER SHEATH AND WITH A BOSTON SCIENTIFIC V-18 GUIDEWIRE. THE AFFECTED PASSEO-18 WAS THEN INTRODUCED INTO THE PATIENTS BODY BUT COULD NOT CROSS THE LESION. THE DEVICE WAS WITHDRAWN AND SCRAPPED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306104 ↗
• MalfunctionJan 27, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (55 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID SFA. AFTER DELIVERING THE DEVICE TO THE LESION, THE BALLOON COULD NOT BE INFLATED. THE DEVICE WAS WITHDRAWN AND WAS FOUND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21243147 ↗
• MalfunctionAug 8, 2024Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR DILATATION OF A SEVERELY CALCIFIED LESION IN THE MILDLY TORTUOUS PROXIMAL TO MID SFA. THE DEVICE WAS FLUSHED WITH SALINE AT THE STRAIGHT PORT AND THE WIRE WAS INSERTED OVER THE BALLOON TIP. THE PASSEO-18 WAS POSITIONED AT THE PROXIMAL SFA AND INFLATED FROM NP 6ATM. THE BALLOON WAS BURST AT 8ATM INSIDE THE VESSEL AT THE PROXIMAL SFA. THE DEVICE WAS THEN REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19945181 ↗
• MalfunctionJan 5, 2022Material Puncture/Hole; Material Puncture/Hole

  A PASSEO 18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A LESION WITH 80 PERCENT STENOSIS DEGREE IN AN ARTERY OF THE LOWER EXTREMITY. DURING THE ATTEMPT TO INFLATE THE BALLOON IN THE TARGET LESION, THE BALLOON WOULD NOT INFLATE. AFTER WITHDRAWAL, THE PHYSICIAN OBSERVED A PINHOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167962 ↗