Passeo-18 2/200/150Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07640130430037), received between Feb 19, 2020 and Nov 28, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2025Material Rupture; Material Rupture

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS PART OF THE LEFT SFA. THE AFFECTED DEVICE WAS POSITIONED IN THE LESION AND INFLATED BUT THE BALLOON BURST PRIOR TO REACHING RBP. THE PRESSURE WAS NOT RECORDED. THE AFFECTED DEVICE WAS WITHDRAWN. ANOTHER BALLOON CATHETER WAS USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23671259 ↗
• MalfunctionJul 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70% STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE DISTAL SFA. THE BALLOON WAS DELIVERED TO THE LESION BUT COULD NOT BE INFLATED. AFTER WITHDRAWAL, A BALLOON LEAKAGE WAS DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552868 ↗
• MalfunctionMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE LEFT MID SFA. IT WAS NOT POSSIBLE TO INFLATE THE PASSEO-18 BALLOON CATHETER. UPON WITHDRAWAL, IT WAS NOTICED THAT LIQUID WAS LEAKING. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021757 ↗
• MalfunctionJan 29, 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 DEVICE WAS INTRODUCED FOR PREDILATATION, BUT THE BALLOON COULD NOT PASS THE LESION. THE DEVICE WAS WITHDRAWN AND SCRAPPED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266958 ↗
• MalfunctionJan 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  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 PROXIMAL FEMORAL ARTERY. THE DEVICE WAS DELIVERED TO THE LESION FOR PREDILATATION, BUT THE BALLOON COULD NOT BE INFLATED. THE DEVICE WAS WITHDRAWN, AND AN IN-VITRO WATER FILLING TEST REVEALED A LEAKAGE. THE MAX. PRESSURE WAS AROUND 5 ATM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21194325 ↗
• MalfunctionJan 7, 2025Fluid/Blood Leak; Inflation Problem; Material Rupture; Fluid/Blood Leak; Inflation Problem; Material Rupture

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF THE MODERATE CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID INFRAPOPLITEAL ARTERY. THE BALLOON COULD NOT BE INFLATED. A BALLOON LEAKAGE WAS FOUND OUTSIDE OF BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093386 ↗
• MalfunctionDec 4, 2023Inflation Problem; Inflation Problem

  A PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF THE PERONEAL ARTERY. AFTER PLACEMENT OF THE DEVICE INSIDE THE BODY, THE BALLOON COULD NOT BE INFLATED. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18263531 ↗
• 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 1ST PASSEO-18 WAS ADVANCED TO THE LESION BUT COULD NOT FURTHER BE INFLATED WHEN THE PRESSURE REACHED 3 ATM (FILED SEPARATELY). THE 2ND PASSEO-18 BALLOON (COMPLAINT DEVICE) WAS USED AFTERWARDS, BUT ALSO RUPTURED. A 3RD PASSEO 18 WAS USED AND ALSO RUPTURED (FILED SEPARATELY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298507 ↗
• MalfunctionMar 14, 2023Inflation Problem; Inflation Problem

  THE PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR PRE-DILATATION OF A MODERATELY CALCIFIED LESION WITH 80 PERCENT STENOSIS DEGREE BELOW THE KNEE. A V18 GUIDEWIRE WAS USED TO REACH THE LESION, AND THE BALLOON WAS PLACED BUT COULD NOT BE DILATED. ANOTHER DEVICE WAS USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541594 ↗
• MalfunctionJun 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR PRE-DILATATION, BUT THE BALLOON COULD NOT BE INFLATED PROPERLY AND UPON REMOVAL A BALLOON LEAKAGE WAS DETECTED. ANOTHER PASSEO-18 WAS USED TO FINISH THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050600 ↗
• MalfunctionFeb 19, 2020Material Rupture; Material Rupture

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR USE. DURING INFLATION THE BALLOON RUPTURED BEFORE REACHING THE RBP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729957 ↗