Passeo-18 2/40/150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130414600), received between Aug 15, 2019 and Jun 4, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR DILATATION OF THE MID PERONEAL ARTERY WITH 80 PERCENT STENOSIS DEGREE. THE BALLOON RUPTURED AT 6 ATM. THEREFORE, ANOTHER PASSEO-18 WAS USED BUT RUPTURED AS WELL (REPORTED SEPARATELY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22146885 ↗
• MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (60 PERCENT STENOSIS DEGREE) IN THE POPLITEAL ARTERY AND PROXIMAL ATA. THE AFFECTED DEVICE WAS FLUSHED WITH SALINE, FOLLOWED BY INSERTION OF A GUIDEWIRE FROM DISTAL DIRECTION. THE DEVICE WAS THEN POSITIONED AT THE DISTAL POPLITEA AND INFLATED UP TO 6 ATM (NP) BUT THE BALLOON DID NOT OPEN. BLOOD WAS NOTED FLOWING BACK INTO THE INFLATION DEVICE. THE PHYSICIAN SUSPECTED A BALLOON BURST AND WITHDREW THE DEVICE. A PASSEO-14 2/40/150 WAS USED TO CONTINUE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20539985 ↗
• MalfunctionSep 9, 2021Material Rupture; Material Rupture

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS PTA. DURING INFLATION IT WAS NOT POSSIBLE TO APPLY MORE THAN 6 ATM. THUS THE BALLOON WAS REMOVED AND IT WAS NOTICED THAT IT HAS BEEN RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12445586 ↗
• MalfunctionAug 15, 2019Failure to Advance; Failure to Advance

  PASSEO-18 BALLOON CATHETERS WERE CHOSEN FOR TREATMENT. DURING THE SAME TREATMENT IT WAS NOT POSSIBLE TO CROSS THE LESION WITH THREE PASSEO-18 BALLOONS WITH DIFFERENT SIZES. FINALLY A ROTABLATOR WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8896339 ↗