Passeo-35 6/150/90Recalls & 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 07640130434325), received between Aug 17, 2021 and Sep 23, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove2
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.
MalfunctionSep 23, 2021Difficult to Remove; Difficult to Remove
THE PASSEO-35 BALLOON WAS SELECTED FOR TREATMENT OF A STENOSIS (80 PERCENT STENOSIS DEGREE IN A MILDLY TORTUOUS DISTAL FSA. AFTER BALLOON DEFLATION (EVEN WITH NEGATIVE PRESSURE), IT WAS DIFFICULT TO PASS THROUGH THE SHEATH FOR WITHDRAWAL AND AFTERWARDS FOR RE-PASSING THROUGH THE SAME SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12519214 ↗MalfunctionAug 17, 2021Difficult to Remove; Difficult to Remove
THE PASSEO-35 BALLOON WAS SELECTED FOR TREATMENT OF A STENOSIS (80 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS DISTAL FSA. AFTER BALLOON DEFLATION (EVEN WITH NEGATIVE PRESSURE), IT WAS DIFFICULT TO PASS THROUGH THE SHEATH FOR WITHDRAWAL AND AFTERWARDS FOR RE-PASSING THROUGH THE SAME SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12333456 ↗
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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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