Passeo-35 Xeo 8/40/90Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130451629), received between Jun 20, 2023 and Oct 1, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (3 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 Rupture3
- Entrapment of Device1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 1, 2025Fracture; Material Rupture; Fracture; Material Rupture
A PASSEO-35 XEO WAS SELECTED FOR TREATMENT OF THE LEFT COMMON ILIAC ARTERY. THE BALLOON RUPTURED DURING DEFLATION TO REMOVE THE BALLOON FROM GUIDEWIRE. THE FIRST PART OF THE BALLOON WAS EXTRACTED THROUGH THE GUIDEWIRE, BUT THE OTHER PART REMAINED IN THE PATIENT. THIS REQUIRED AN EXTENSIVE SURGICAL APPROACH TO EXTRACT THE MISSING PART AND THE USE OF A SURGICAL PATCH.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23189248 ↗MalfunctionFeb 7, 2024Entrapment of Device; Material Rupture; Entrapment of Device; Material Rupture
A PASSEO-35 XEO BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (50 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS PROXIMAL SFA. THE PASSEO-35 XEO BURST AT A PRESSURE OF 9 ATM. SINCE IT WAS NOT POSSIBLE TO PULL THE BALLOON OUT THROUGH THE SHEATH, IT WAS REMOVED ALL TOGETHER. NOTHING REMAINED IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18658437 ↗InjuryJun 20, 2023Material Rupture; Material Rupture
DURING A PTA SHUNT PROCEDURE, THE PASSEO-35 XEO BALLOON WAS INFLATED UP TO 22 ATM AND RUPTURED CIRCULAR. A PART OF THE BALLOON REMAINED IN THE VESSEL WHEN IT WAS REMOVED. THE REMAINING PART OF THE BALLOON WAS REMOVED BY SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17163902 ↗
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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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