Passeo-35 Xeo 7/40/90Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640130451612), received between Mar 25, 2025 and Aug 7, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (2 reports).
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 Rupture2
- Fracture1
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.
InjuryAug 7, 2025Fracture; Material Rupture; Fracture; Material Rupture
A PASSEO-35 XEO WAS SELECTED FOR A VENOUS RECANALIZATION PROCEDURE. THE DEVICE RUPTURED, LEAVING PARTS OF IT (INCLUDING THE TIP, A SECTION OF THE CATHETER, AND THE BALLOON) INSIDE THE PATIENT'S VEIN. A SECOND PUNCTURE WAS NECESSARY TO RETRIEVE THE REMAINING PART, WHICH EXTENDED THE DURATION OF THE PROCEDURE AND THE PATIENT'S ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22735208 ↗MalfunctionMar 25, 2025Material Rupture; Material Rupture
THE PASSEO-35 XEO PERIPHERAL DILATATION CATHETER WAS SELECTED FOR TREATMENT. THE BALLOON RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21687687 ↗
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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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