Passeo-18 5/200/90Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640130429888), received between Sep 28, 2021 and Jan 10, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.

• InjuryJan 10, 2023Fracture; Fracture

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR AN ANTEGRADE TREATMENT OF THE AFS TOGETHER WITH A COMMAND .018 WIRE. DURING DILATATION OF THE BALLOON UP TO NP PRESSURE, THE BALLOON RUPTURED AND WAS WITHDRAWN BUT KEPT HOOKING AT THE END OF THE 4F SHEATH. WHEN THE BALLOON CATHETER WAS OUT OF THE PATIENT, IT WAS SEEN THAT THE BALLOON WAS NOT COMPLETE, SOME PARTS DID REMAIN IN THE AFS. REMOVAL OF THESE PARTS OUT OF THE VESSEL WAS NOT SUCCESSFUL, IT WAS DECIDED TO STOP THE PROCEDURE. A BYPASS SURGERY IS PLANNED SOON.

  Patient problems: Insufficient Information

  MAUDE report 16134396 ↗
• MalfunctionSep 23, 2022Fracture; Fracture

  A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE POPLITEAL ARTERY. WHILE INFLATING THE BALLOON INSIDE THE PATIENT, THE PATIENT MOVED HIS KNEE AND THE BALLOON RUPTURED. UPON REMOVING, THE BALLOON FRACTURED IN TWO PARTS. ALL PARTS WERE REMOVED FROM PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15469722 ↗
• MalfunctionDec 14, 2021Material Rupture; Material Rupture

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON RUPTURED DURING ITS FIRST INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003204 ↗
• MalfunctionSep 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON WAS PLACED PROPERLY INSIDE THE LESION. AS THE BALLOON WAS INFLATED UP TO 6 BAR THE PRESSURE OF THE BALLOON WOULD SLOWLY TURN DOWN. TO KEEP THE BALLOON INFLATED AT 6 BAR IT WAS NECESSARY TO KEEP ON GIVING MORE PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540817 ↗
• MalfunctionSep 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON WAS PLACED PROPERLY INSIDE THE LESION. AS THE BALLOON WAS INFLATED UP TO 6 BAR THE PRESSURE OF THE BALLOON WOULD SLOWLY TURN DOWN. TO KEEP THE BALLOON INFLATED AT 6 BAR IT WAS NECESSARY TO KEEP ON GIVING MORE PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540808 ↗
• MalfunctionSep 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON WAS PLACED PROPERLY INSIDE THE LESION. AS THE BALLOON WAS INFLATED UP TO 6 BAR THE PRESSURE OF THE BALLOON WOULD SLOWLY TURN DOWN. TO KEEP THE BALLOON INFLATED AT 6 BAR IT WAS NECESSARY TO KEEP ON GIVING MORE PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540775 ↗
• MalfunctionSep 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON WAS PLACED PROPERLY INSIDE THE LESION. AS THE BALLOON WAS INFLATED UP TO 6 BAR THE PRESSURE OF THE BALLOON WOULD SLOWLY TURN DOWN. TO KEEP THE BALLOON INFLATED AT 6 BAR IT WAS NECESSARY TO KEEP ON GIVING MORE PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540773 ↗