Passeo-18 2/80/150Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640130414655), received between Nov 18, 2021 and May 6, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (1 report).
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 Problem1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2022Inflation Problem; Inflation Problem
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF THE SFA. DURING THE PROCEDURE, THE BALLOON COULD NOT BE FULLY DILATED. THE PHYSICIAN USED ANOTHER BALLOON TO FINISH THE DILATATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14310594 ↗MalfunctionNov 18, 2021Material Rupture; Material Rupture
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (60 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS ANTERIOR TIBIAL ARTERY. THE BALLOON WAS PLACED IN THE LESION AND INFLATED UP TO 6 BAR. THEN, IMAGING SHOWED LEAKING CONTRAST MEDIUM. THE DEVICE WAS WITHDRAWN AND ANOTHER BALLOON WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12834609 ↗
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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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