Passeo-18 6/120/130Recalls & reported problems
Biotronik AG · Class 2
All models of Passeo-18 (54)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130414693), received between Sep 16, 2019 and May 6, 2020 — classified as 3 malfunctions.
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.
Most reported problems
Device problems
- Material Rupture3
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2020Material Rupture; Material Rupture
A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE SFA. AN INFLATION DEVICE WAS USED. AT 10 BAR PRESSURE THE BALLOON RUPTURED AND HAD TO BE REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10030976 ↗MalfunctionSep 16, 2019Material Rupture
A PASSEO-18 BALLOON CATHETER WAS CHOSEN TO DILATE A SEVERE CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE DISTAL SFA. DURING INFLATION THE PASSEO-18 BALLOON RUPTURED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9071218 ↗MalfunctionSep 16, 2019Material Rupture; Material Rupture
A PASSEO-18 BALLOON CATHETER WAS CHOSEN TO DILATE A SEVERE CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE DISTAL SFA. DURING INFLATION THE PASSEO-18 BALLOON RUPTURED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9071216 ↗
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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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