Passeo-35 Xeo 9/40/90Recalls & reported problems
Biotronik AG · Class 2
All models of Passeo-35 Xeo (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640130451636), received between Apr 16, 2026 and Apr 16, 2026 — classified as 1 death.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Material Rupture1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathApr 16, 2026Fracture; Material Rupture
DURING A FISTULAGRAM, AN IN-STENT RESTENOSIS WAS FOUND. THE PASSEO-35 XEO PERIPHERAL DILATATION CATHETER WAS USED FOR THE TREATMENT BUT WHILE INFLATING, THE BALLOON RUPTURED. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE BALLOON, BUT THEY WERE UNSUCCESSFUL, AND THE BALLOON SEPARATED INTO 2 PIECES, WITH A PORTION CONTINUING TO MIGRATE FURTHER THE PATIENT. JUST ABOUT 1/4 OF THE BALLOON WAS ABLE TO BE REMOVED. THE PATIENT WAS TRANSPORTED FROM THE OUTPATIENT CENTER TO THE HOSPITAL FOR FURTHER EVALUATION AND INTERVENTION. THE NEXT DAY, WHEN THE HOSPITAL DECIDED TO PERFORM ANOTHER PROCEDURE TO REMOVE THE REMAINING PARTS OF THE DEVICE, THE PATIENT PASSED AWAY.
Patient problems: Insufficient Information
MAUDE report 24893426 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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