Passeo-35 5/60/80Recalls & 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
- 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 07640119558233), received between Apr 30, 2020 and May 11, 2022 — 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 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
- Inflation Problem1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2022Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem
A PASSEO-35 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF THE POPLITEAL ARTERY. THE DEVICE WAS ADVANCE OVER THE WIRE TO THE TARGET LESION AND WAS INFLATED UP TO 13 BAR. THE BALLOON COULD NOT BE INFLATED FURTHER AND LEAKING OF CONTRAST WAS OBSERVED IN THE FLUOROSCOPY. BLOOD WAS ALSO OBSERVED IN THE SYRINGE OF THE INFLATION DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14364789 ↗MalfunctionApr 30, 2020Leak/Splash; Leak/Splash
THE PASSEO-35 BALLOON WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION IN THE RCA. DURING THE INTERVENTION IT WAS NOTICED THAT THE BALLOON IS PERFORATED IN THE MIDDLE AND COULD NOT BE USED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10014423 ↗
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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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