Passeo-18 2.5/200/130Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07640130430044), received between Jul 24, 2019 and Jan 7, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2025Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole; Fluid/Blood Leak; Inflation Problem; Material Puncture/Hole

  THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A LESION WITH 75 PERCENT STENOSIS DEGREE IN A MILDLY TORTUOUS PART OF THE DISTAL INFRAPOPLITEAL ARTERY. THE BALLOON WAS USED FOR PRE-DILATATION, BUT IT COULD NOT INFLATE. THE DEVICE WAS WITHDRAWN, AND A BALLOON LEAKAGE WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093442 ↗
• MalfunctionOct 4, 2023Material Rupture; Material Rupture

  A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF THE TIBIAL-PERONEAL TRUNK. DURING INFLATION, WHEN THE PRESSURE REACHED 2 BAR, THE BALLOON RUPTURED. THE PATIENT WAS STABLE, NO FURTHER ACTIONS WERE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871087 ↗
• MalfunctionFeb 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (75 PERCENT STENOSIS DEGREE IN THE MILDLY TORTUOUS ANTERIOR TIBIAL ARTERY. A 5F SHORT SHEATH WAS INSERTED INTO THE RIGHT COMMON FEMORAL ARTERY. 0.18 INCH WIRE IS USED TO CANNULATE PASS THE LESION IN THE ANTERIOR TIBIAL ARTERY. THE WIRE IS PARKED AT THE DISTAL ANTERIOR TIBIAL ARTERY. THE BALLOON WAS THEN INFLATED TO 6 ATM. BALLOON PRESSURE UNABLE TO STAY AT 6 ATM. ON THE ANGIOGRAM, CONTRAST CAN BE SEEN LEAKING OUT FROM THE BALLOON. BALLOON IS PROPERLY DEFLATED AND REMOVED OUT OF THE PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383831 ↗
• MalfunctionAug 5, 2021Material Rupture; Material Rupture

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON RUPTURED BELOW RBP DURING DILATATION OF POSTERIOR TIBIAL AND FIBULAR ARTERIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12280368 ↗
• MalfunctionAug 21, 2019Mechanical Problem; Mechanical Problem

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. INITIALLY IT WAS REPORTED THAT THE GUIDE WIRE WAS STUCK IN THE GUIDE WIRE LUMEN OF THE PASSEO-18 SYSTEM AND COULD NOT BE WITHDRAWN. AFTER RETURN OF THE PRODUCT IT WAS DETECTED THAT THE GUIDE WIRE HAS FRACTURED AND A PART REMAINED IN THE GUIDE WIRE LUMEN OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915775 ↗
• 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 8896338 ↗
• MalfunctionJul 24, 2019Inflation Problem; Inflation Problem

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON COULD NOT BE INFLATED DURING PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824078 ↗
• MalfunctionJul 24, 2019Inflation Problem; Inflation Problem

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON COULD NOT BE INFLATED DURING PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824071 ↗