Passeo-35 6/120/130Recalls & 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 07640130434615), received between May 20, 2021 and May 20, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
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.
MalfunctionMay 20, 2021Material Rupture; Material Rupture
THE PASSEO-35 BALLOON WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS SFA. THE BALLOON WAS INFLATED AT 4 BAR AND THE PRESSURE COULD NOT BE INCREASED ANYMORE. DURING THE ATTEMPT TO DEFLATE AND INFLATE THE BALLOON AGAIN, BLOOD APPEARED IN THE SYRINGE OF THE INFLATION DEVICE. THE BALLOON WAS CONFIRMED BURST WHEN IT WAS TAKEN OUT AND FLUSH WITH SALINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11860318 ↗
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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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