Passeo-35 Xeo 6/40/130Recalls & reported problems
Biotronik AG · Class 2
All models of Passeo-35 Xeo (17)
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 07640130452343), received between Feb 7, 2025 and Mar 25, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Handling Problem” (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.
Reports received per month
Most reported problems
Device problems
- Device Handling Problem1
- Failure to Advance1
- Inflation Problem1
- Material Deformation1
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.
MalfunctionMar 25, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
THE PASSEO-35 XEO PERIPHERAL DILATATION CATHETER WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PART OF THE MID SFA. THE BALLOON WAS DELIVERED TO THE LESION BUT COULD NOT PASS THE LESION. THE DEVICE WAS WITHDRAWN AND THE DELIVERY SHAFT WAS FOUND KINKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21692848 ↗MalfunctionFeb 7, 2025Inflation Problem; Device Handling Problem; Inflation Problem; Device Handling Problem
THE PASSEO-35 XEO BALLOON CATHETER WAS CHOSEN FOR THE TREATMENT. THE BALLOON COULD NOT BE INFLATED IN THE VENOUS STENOSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21336296 ↗
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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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