Passeo-18 5/150/130Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07640130414761), received between Aug 13, 2020 and Aug 7, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Failure to Unfold or Unwrap

  The Passeo-18 peripheral balloon catheter was selected for treatment of a severely calcified lesion in a moderately tortuous segment of the SFA. The balloon inflated only proximally and failed to fully expand despite inflation to 4 atm and reinflation attempts. The balloon was removed and replaced with another balloon of the same size, which functioned normally without any issues.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50173434 ↗
• MalfunctionMay 21, 2024Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  ATTEMPTED INFLATION OF THE PASSEO-18 BALLOON (COMPLAINT DEVICE) AT SITE OF LESION IN SFA (80 PERCENT STENOSIS DEGREE). UPON STARTING INFLATION, NO VISIBLE CONTRAST WAS SEEN. NEGATIVE PRESSURE WAS PULLED ON SYRINGE AND BLOOD WAS WITHDRAWN IN LINE, INDICATING BALLOON RUPTURE OR HOLE. THIS BALLOON WAS WITHDRAWN, AND ANOTHER PASSEO-18 WITH SAME LOT (REPORTED SEPARATELY) WAS OPENED AND REINSERTED. WHILE ATTEMPTING ANOTHER INFLATION, THE SAME INCIDENT HAPPENED. BALLOON WAS WITHDRAWN AND REPLACED WITH LIKE SIZE COMPETITIVE BALLOON. THE COMPETITIVE BALLOON INFLATED WITH NO ISSUE AND PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360029 ↗
• MalfunctionMay 21, 2024Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  ATTEMPTED INFLATION OF THE PASSEO-18 BALLOON (REPORTED SEPARATELY) AT SITE OF LESION IN SFA (80 PERCENT STENOSIS DEGREE). UPON STARTING INFLATION, NO VISIBLE CONTRAST WAS SEEN. NEGATIVE PRESSURE WAS PULLED ON SYRINGE AND BLOOD WAS WITHDRAWN IN LINE, INDICATING BALLOON RUPTURE OR HOLE. THIS BALLOON WAS WITHDRAWN, AND ANOTHER PASSEO-18 WITH SAME LOT (COMPLAINT DEVICE) WAS OPENED AND REINSERTED. WHILE ATTEMPTING ANOTHER INFLATION, THE SAME INCIDENT HAPPENED. BALLOON WAS WITHDRAWN AND REPLACED WITH LIKE SIZE COMPETITIVE BALLOON. THE COMPETITIVE BALLOON INFLATED WITH NO ISSUE AND PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359950 ↗
• MalfunctionJan 12, 2024Inflation Problem; Inflation Problem

  A PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERE STENOSIS (70 PERCENT STENOSIS DEGREE) IN THE LEFT SFA. AFTER PRE-DILATATION WITH A SMALLER PASSEO-18, THE COMPLAINT PASSEO-18 WAS USED, BUT THE BALLOON COULD NOT BE INFLATED AFTER IT REACHED THE LESION. THE PRESSURE WAS VERY LOW AND DID NOT RECORD. ANOTHER DEVICE WAS USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502399 ↗
• InjuryFeb 28, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (85 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS OSTIAL SEGMENT OF THE LEFT SFA. DURING PRE-DILATATION A LEAKAGE OF THE PASSEO-18 WAS DETECTED. THE BALLOON WAS REMOVED, AND THE BALLOON WAS FOUND FRACTURED INSIDE THE BODY. THE FRACTURED PARTS IN THE VESSEL WERE FINALLY REMOVED BY SURGERY, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16451914 ↗
• MalfunctionJul 29, 2022Failure to Advance; Failure to Advance

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A 200MM LONG LESION WITH 95 PERCENT STENOSIS DEGREE IN THE LOWER LIMB ARTERY. DESPITE PRE-DILATATION, THE LESION COULD NOT BE CROSSED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15129213 ↗
• MalfunctionJul 5, 2022Material Rupture; Material Rupture

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS RIGHT LOWER LIMB ARTERY. THE DEVICE WAS USED FOR PRE-DILATATION. DURING INFLATION THE PRESSURE REACHED SIX BAR, BUT THEN WENT DOWN TO ZERO. IT WAS NOTICED THAT THE BALLOON HAS RUPTURED. THE PASSEO-18 WAS REMOVED AND ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14919617 ↗
• MalfunctionJun 29, 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 USE OF THE FIRST THREE PASSEO-18, THE COMPLAINT PASSEO-18 DEVICE WAS USED FOR DILATATION BUT RUPTURED. FINALLY, THE PHYSICIAN USED ANOTHER PASSEO-18 TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14851816 ↗
• MalfunctionNov 16, 2021Material Rupture; Material Rupture

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS OSTIAL SFA. AFTER PLACING THE DEVICE IN THE PRE-DILATED TARGET LESION, THE BALLOON WAS INFLATED UP TO 6 BAR. AFTER 1 MINUTE IT WAS DETECTED THAT CONTRAST MEDIUM LEAKED OUT OF THE BALLOON AND THE PRESSURE WENT DOWN. THE DEVICE WAS WITHDRAWN, AND ANOTHER BALLOON WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12821000 ↗
• MalfunctionAug 13, 2020Material Rupture; Material Rupture

  A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE MID SUPERFICIAL FEMORAL ARTERY. THE BALLOON BURST AT 12 ATM DURING INFLATION IN THE TARGET LESION. THE INTERVENTION WAS SUCCESSFULLY COMPLETED BY USING ANOTHER PASSEO-18 WITH SAME SIZE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10403560 ↗