Passeo-18 5/60/90Recalls & 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 07640119558776), received between Dec 16, 2020 and Jul 11, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak2
- Material Rupture2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION WITH 90 PERCENT STENOSIS DEGREE IN THE MODERATELY TORTUOUS DISTAL BRACHIAL ARTERY. DURING ATTEMPT TO INFLATE THE BALLOON, THE PRESSURE WAS NOT MAINTAINED AND THE BALLOON WAS DEFLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17298490 ↗MalfunctionSep 29, 2021Fluid/Blood Leak; Fluid/Blood Leak
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON WAS PLACED PROPERLY INSIDE THE LESION. AS THE BALLOON WAS INFLATED UP TO 6 BAR THE PRESSURE OF THE BALLOON WOULD SLOWLY TURN DOWN. TO KEEP THE BALLOON INFLATED AT 6 BAR IT WAS NECESSARY TO KEEP ON GIVING MORE PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12548014 ↗MalfunctionDec 16, 2020Material Rupture; Material Rupture
TWO PASSEO-18 BALLOON CATHETERS WERE CHOSEN FOR THE TREATMENT DURING THE SAME PROCEDURE. THE BALLOONS BURST DURING PROCEDURE. THE SECOND PASSEO-18 IS REPORTED SEPARATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11018718 ↗MalfunctionDec 16, 2020Material Rupture; Material Rupture
TWO PASSEO-18 BALLOON CATHETERS WERE CHOSEN FOR THE TREATMENT DURING THE SAME PROCEDURE. THE BALLOONS BURST DURING PROCEDURE. THE SECOND PASSEO-18 IS REPORTED SEPARATELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11018711 ↗
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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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