Passeo-35 3/80/90Recalls & reported problems
Biotronik AG · Class 2
All models of Passeo-35 (24)
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 07640130434172), received between Nov 28, 2023 and Apr 29, 2024 — classified as 2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- 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.
MalfunctionApr 29, 2024Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem
A PASSEO-35 WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (STENOSIS DEGREE: 80 PERCENT) IN THE MODERATELY TORTUOUS MID ARTERIOVENOUS FISTULA. THE PATIENT WAS PREPARED, AND GUIDEWIRE WAS INSERTED, FOLLOWED BY THE INSERTION OF THE PASSEO-35 BALLOON FOR PRE-DILATATION. HOWEVER, THE BALLOON FAILED TO INFLATE PROPERLY. IT COULD NOT BE INFLATED TO THE NOMINAL PRESSURE. THE BALLOON WAS WITHDRAWN AND REPLACED WITH THE SAME MODEL AND INFLATED NORMALLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19207948 ↗MalfunctionNov 28, 2023Material Rupture; Material Rupture
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN AN AV FISTULA. THE DEVICE WAS USED FOR PRE-DILATATION, BUT THE BALLOON COULD NOT BE INFLATED ANYMORE WHEN IT REACHED 6 ATM. ANOTHER BALLOON WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18219428 ↗
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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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