Passeo-18 3/120/130Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640119559193), received between Aug 6, 2019 and Jan 29, 2026 — 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.

• MalfunctionJan 29, 2026Material Puncture/Hole; Material Rupture

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF THE PROXIMAL ANTERIOR TIBIAL ARTERY. THE DEVICE WAS INTRODUCED FOR AN ANGIOPLASTY PROCEDURE, BUT IT BURST BEFORE REACHING NOMINAL PRESSURE. THE BURST BALLOON WAS REMOVED AND REPLACED BY A BALLOON FROM ANOTHER COMPANY, WHICH WAS SUCCESSFULLY INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209608 ↗
• MalfunctionApr 14, 2025Material Rupture; Material Rupture

  DURING THE PASSAGE OF THE PASSEO-18 PERIPHERAL DILATION CATHETER, THE BALLOON WAS INTRODUCED INTO A PRE-DILATED MILDLY CALCIFIED LESION IN THE POSTERIOR TIBIAL ARTERY. HOWEVER, AT A PRESSURE OF 10 ATM, THE BALLOON RUPTURED. THE DEVICE WAS WITHDRAWN, NO PART REMAINED IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21836997 ↗
• MalfunctionMar 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE MID POPLITEAL ARTERY. IT WAS NOT POSSIBLE TO INFLATE THE BALLOON. AFTER WITHDRAWAL OF THE DEVICE A LEAKAGE OF THE BALLOON WAS DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655331 ↗
• MalfunctionMay 1, 2024Material Puncture/Hole; Material Puncture/Hole

  A PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (STENOSIS DEGREE: 50 PERCENT) IN THE MODERATELY TORTUOUS POSTERIOR TIBIAL ARTERY (PTA). THE PASSEO-18 WAS INFLATED AT THE PTA LESION AT 6 ATM. HOWEVER, AS THE BALLOON WAS INFLATING, IT WAS OBSERVED THAT BLOOD WAS FLOWING INTO THE INFLATION DEVICE. IT WAS SUSPECTED THAT THE BALLOON WAS RUPTURED BUT THE BALLOON WAS ABLE TO INFLATE AND MAINTAINED AT 6 ATM EVEN THOUGH BLOOD CONTINUE TO FLOW INTO THE INFLATION DEVICE. THE BALLOON WAS DEFLATED AND REMOVED FROM THE PATIENT WITHOUT DIFFICULTIES. A NEW BALLOON WAS USED AND THE LESION SUCCESSFULLY DILATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219900 ↗
• MalfunctionJan 21, 2021Material Rupture; Material Rupture

  A PASSEO 18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS ULNAR ARTERY. DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11209195 ↗
• MalfunctionAug 6, 2019Leak/Splash; Leak/Splash

  THE PASSEO-18 BALLOON CATHETER WAS SELECTED FOR USE. AFTER UNPACKING THE DOCTOR INJECTED THE BALLOON WITH HEPARINIZED SALINE TO FLUSH. THEREBY IT WAS NOTED THAT THE LUMEN COULD NOT BE FLUSHED PROPERLY AND A LEAKAGE WAS DETECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8866651 ↗