Passeo-35 Xeo 7/80/130Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640130452534), received between Jan 15, 2025 and Jan 15, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
- Material Rupture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 15, 2025Fracture; Material Rupture; Fracture; Material Rupture
THE PASSEO-35 XEO BALLOON CATHETER WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION WITH 90 PERCENT STENOSIS DEGREE IN THE POSTERIOR TIBIAL ARTERY (PTA). DURING ATTEMPT OF PRE-DILATATION, THE PASSEO-35 XEO RUPTURED AT 15ATM. IT WAS ATTEMPTED TO REMOVE THE DEVICE BUT THE DEVICE FRACTURED AND A PART OF THE BALLOON REMAINED IN PATIENT. THE PATIENT WAS TRANSFERRED TO THE OPERATION ROOM TO REMOVE THE FRACTURED PART. FINALLY, PATIENT WAS DISCHARGED HOME WITH NO FURTHER COMPLICATION.
Patient problems: Foreign Body In Patient
MAUDE report 21159682 ↗
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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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