Biotronik Passeo-35 HP 4/40/75Recalls & reported problems
Creagh Medical Limited · Class 2
All models of Biotronik Passeo-35 HP (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05391525781433), received between Jan 15, 2018 and Jan 15, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation 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.
Most reported problems
Device problems
- Inflation Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2018Inflation Problem; Inflation Problem
THE PHYSICIAN TRIED TO INFLATE THE PASSEO-35HP BALLOON UP TO 20 ATM IN AVF WITH APPROXIMATELY 70% STENOSIS. DURING THE ATTEMPT, A POSSIBLE BALLOON TEAR WAS OBSERVED UNDER ANGIOGRAPHY; THE BALLOON HAD FAILED TO FULLY INFLATE AND THE SHAPE OF THE BALLOON LOOKED LIMP, EVEN SHOWING SLIGHT LEAK OF THE INFLATION MEDIUM. AFTER WITHDRAWING THE DEFECT DEVICE, A NEW PASSEO-35HP OF THE SAME SIZE WAS USED TO COMPLETE THE TREATMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7190040 ↗
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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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