Passeo-35 4/150/130Recalls & reported problems
Biotronik AG · Class 2
All models of Passeo-35 (24)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130434639), received between Mar 9, 2021 and Dec 11, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Inflation Problem1
- Material Puncture/Hole1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 11, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
THE PASSEO-35 BALLOON SYSTEM WAS SELECTED FOR PRE-DILATATION OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS PROXIMAL SFA, BUT THE BALLOON WAS LEAKING DURING INFLATION. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20906050 ↗MalfunctionMar 23, 2021Inflation Problem; Inflation Problem
THE PASSEO-35 BALLOON CATHETER WAS SELECTED FOR THE TREATMENT OF A CALCIFIED LESION IN THE SFA. ALTHOUGH THE DOCTOR TRIED FOR SEVERAL TIMES, THE BALLOON COULD NOT BE INFLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11554042 ↗MalfunctionMar 9, 2021Material Rupture; Material Rupture
THE PASSEO-35 BALLOON WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE, LENGTH 200MM) IN THE SFA. THE BALLOON WAS INFLATED BUT BURST AT 18 BAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11448500 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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