Passeo-35 Xeo 6/60/130Recalls & 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
- 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 07640130452435), received between Oct 25, 2023 and Oct 25, 2023 — 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.
MalfunctionOct 25, 2023Material Rupture; Material Rupture
A PASSEO-35 XEO BALLOON CATHETER WAS SELECTED FOR TREATMENT OF THE SFA. THE DEVICE WAS POSITIONED AT THE MID SFA AND INFLATED AT NP FOR 3 MINUTES. THE BALLOON WAS DEFLATED AND PULLED BACK FOR FURTHER INFLATION AT THE PROX. SEGMENT OF THE SFA. IT WAS NOTICED THAT THE BALLOON COULD NOT BE INFLATED WITH THE INFLATION DEVICE. THE BALLOON WAS REMOVED FROM PATIENT AND A BALLOON RUPTURE WAS DETECTED. THE BALLOON WAS REPLACED TO CONTINUE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18004692 ↗
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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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