Passeo-18 5/200/130Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07640130430082), received between Jun 10, 2021 and Aug 8, 2022 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2022Material Rupture; Material Rupture

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MILDLY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS MID SFA. THE BALLOON RUPTURED DURING INFLATION AT 8 ATM. UDI (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188125 ↗
• MalfunctionJun 21, 2022Material Puncture/Hole; Material Puncture/Hole

  TOTALLY, 5 PASSEO-18 WERE USED FOR PRE-DILATATION DURING TREATMENT OF AN ARTERIAL OCCLUSION IN BOTH LOWER LIMBS . AFTER THE USE OF THE FIRST TWO PASSEO-18, THE PHYSICIAN FOUND BLOOD RETURNING DURING DILATATION OF THE PASSEO-18 5/200. THE BALLOON WAS WITHDRAWN AND WAS FOUND TO BE RUPTURED. FINALLY, THE PHYSICIAN USED ANOTHER PASSEO-18 TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754809 ↗
• 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 13003252 ↗
• MalfunctionJul 30, 2021Decrease in Pressure; Decrease in Pressure

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. IT WAS ATTEMPTED TO INFLATE THE BALLOON UP TO 5 BAR, BUT TO KEEP IT AT 5 BAR IT WAS NECESSARY TO GIVE MORE PRESSURE. EVENTUALLY THE PASSEO-18 HAD TO BE REPLACED BY ANOTHER BALLOON AS IT COULD NOT BE USED ANYMORE. LOT NUMBER AND EVENT DATE ARE UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252907 ↗
• MalfunctionJul 30, 2021Decrease in Pressure; Decrease in Pressure

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. IT WAS ATTEMPTED TO INFLATE THE BALLOON UP TO 5 BAR, BUT TO KEEP IT AT 5 BAR IT WAS NECESSARY TO GIVE MORE PRESSURE. EVENTUALLY THE PASSEO-18 HAD TO BE REPLACED BY ANOTHER BALLOON AS IT COULD NOT BE USED ANYMORE. LOT NUMBER AND EVENT DATE ARE UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252899 ↗
• MalfunctionJul 20, 2021Material Rupture; Material Rupture

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS MID SFA. THE BALLOON BURST DURING INFLATION UP TO 12ATM. ANOTHER PASSEO-18 WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196889 ↗
• MalfunctionJun 10, 2021Material Puncture/Hole; Material Puncture/Hole

  A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION. THE BALLOON WAS PLACED PROPERLY IN THE LESION. IT WAS ATTEMPTED TO INFLATE THE BALLOON AS USUAL. GOING UP TO NP WAS POSSIBLE WITHOUT PROBLEMS BUT WHEN ARRIVING AT 5 ATM, THE PRESSURE OF THE BALLOON WOULD SLOWLY TURN DOWN. TO KEEP THE BALLOON INFLATED AT 5 ATM MORE PRESSURE NEEDED TO BE APPLIED. A NEW BALLOON WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980306 ↗