Passeo-18 2/170/150Recalls & reported problems
Biotronik AG · Class 2
All models of Passeo-18 (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130414792), received between Oct 4, 2019 and May 15, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (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
Device problems
- Inflation Problem2
- Material Puncture/Hole1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2023Inflation Problem; Inflation Problem
THE PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS INFRAPOPLITEAL ARTERY. THE BALLOON COULD NOT BE INFLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16936589 ↗MalfunctionFeb 24, 2021Material Rupture; Material Rupture
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR THE TREATMENT OF A SEVERELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE DORSALIS PEDIS ARTERY. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE INTERVENTION WAS COMPLETED WITH ANOTHER BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11373610 ↗MalfunctionDec 7, 2020Inflation Problem; Inflation Problem
A PASSEO 18 BALLOON CATHETER WAS CHOSEN FOR THE TREATMENT OF A SEVERELY CALCIFIED LESION IN THE ARTERIAE TIBIALIS ANTERIOR. THE PASSEO 18 BALLOON WAS USED TO DILATE THE LESION. ALTHOUGH THE PRESSURE COULD NOT BE MAINTAINED, IT WAS TRIED SEVERAL TIMES, BUT THE BALLOON STILL COULD NOT BE FILLED DURING THE EXPANSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10960079 ↗MalfunctionOct 4, 2019Material Puncture/Hole; Material Puncture/Hole
THE PASSEO-18 BALLOON CATHETER WAS SELECTED FOR THE TREATMENT OF A CALCIFIED LESION. AFTER LESION CROSSING AND POSITIONING THE PASSEO-18 BALLOON COULD NOT BE INFLATED AND A PINHOLE WAS SUSPECTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9158910 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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