Passeo-35 Xeo 7/20/90Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640130451520), received between Nov 10, 2025 and Nov 10, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Activation Problem” (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
- Activation Problem1
- Malposition of Device1
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.
InjuryNov 10, 2025Malposition of Device; Activation Problem; Malposition of Device; Activation Problem
A PULSAR-18 T3 STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED VENOUS STENOSIS IN AN ARTERIOVENOUS FISTULA. PRE-DILATATION WITH 2 BALLOONS (4/20 MM, 5/20 MM) WAS INEFFECTIVE. THE PULSAR-18 T3 WAS THEN IMPLANTED VIA A 4F SHEATH, BUT AFTER ONE-THIRD DEPLOYMENT, THE STENT MIGRATED INTO THE DILATED VENOUS SEGMENT, LEAVING TWO-THIRDS UNDEPLOYED.
Patient problems: Foreign Body In Patient
MAUDE report 23508243 ↗
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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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