Passeo-14 1.5/70/150Recalls & reported problems
Biotronik AG · Class 2
All models of Passeo-14 (13)
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 07640130433618), received between Sep 15, 2022 and Dec 15, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak2
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.
MalfunctionDec 15, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE PASSEO-14 BALLOON CATHETER WAS SELECTED FOR TREATMENT. THE PASSEO-14 BALLOON COULD NOT BE INFLATED AS IT REACHED THE LESION BELOW THE KNEE. UPON REMOVAL A LEAKAGE WAS FOUND IN THE BALLOON, AND ANOTHER DEVICE WAS USED FOR THE PROCEDURE. THE BALLOON WAS SCRAPPED BY THE HOSPITAL AND COULD NOT BE RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15986441 ↗MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE PASSEO-14 BALLOON CATHETER WAS USED FOR PRE-DILATATION OF A MODERATELY CALCIFIED LESION WITH 70 PERCENT STENOSIS DEGREE, BUT THE BALLOON COULD NOT BE INFLATED AND A LEAKAGE WAS FOUND AFTER WITHDRAWAL. ANOTHER BALLOON WAS USED TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15433425 ↗
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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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