Passeo-35 7/60/80Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640119558257), received between Sep 13, 2023 and Sep 13, 2023 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION WITH 80 PERCENT STENOSIS DEGREE IN THE MODERATELY TORTUOUS SFA. THE BALLOON EASILY REACHED THE LESION WITHOUT RESISTANCE AND WITHOUT USING FORCE. WHEN THE BALLOON INFLATION WAS ATTEMPTED, THERE WAS NO READING ON THE ATM DIAL AND THE BALLOON WAS NOT INFLATING ON FLUORO. IT WAS NOTICED THAT THE INFLATION FLUID WAS IN FACT LEAKING OUT OF THE WIRE LUMEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17735781 ↗
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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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