Passeo-35 Xeo 4/40/90Recalls & 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
- 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 07640130451582), received between Jun 4, 2025 and Jun 4, 2025 — 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.
Reports received per month
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.
MalfunctionJun 4, 2025Material Rupture; Material Rupture
THE PAASSEO-35 XEO PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT IN A MILDLY CALCIFIED LESION. WHEN THE BALLOON WAS INFLATED, IT RUPTURED EVEN WHEN IT WAS DEFLATED, SLOWER THAN THE NORMAL RATE. IT WAS REPORTED THAT THE PATIENT WAS NOT INJURED AND THAT THE INTERVENTION WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22140978 ↗
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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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