Passeo-18 5/80/130Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640119559179), received between Jun 11, 2020 and Nov 14, 2025 — classified as 4 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.
Reports received per month
Most reported problems
Device problems
- Material Rupture3
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2025Material Rupture; Material Rupture
THE PASSEO-18 PERIPHERAL BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (>80 % STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE POPLITEAL ARTERY. THE AFFECTED DEVICE WAS POSITIONED IN THE TARGET LESION AND INFLATED TO 5 ATM DURING WHICH THE BALLOON BURST. THE AFFECTED DEVICE WAS SUCCESSFULLY WITHDRAWN. AFTER ADDITIONAL CORRESPONDENCE WITH THE LOCAL STAFF, IT WAS CONFIRMED THAT THE DEVICE DID NOT LEAK DURING INFLATION. UNFORTUNATELY, THE DEVICE IS NO LONGER AVAILABLE AS IT WAS DISPOSED OF DUE TO BLOOD CONTAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23553021 ↗MalfunctionOct 3, 2022Failure to Advance; Failure to Advance
A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION WITH 65 PERCENT STENOSIS DEGREE IN A MODERATELY TORTUOUS VESSEL. THE LESION COULD NOT BE PASSED WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15528586 ↗MalfunctionJul 19, 2022Material Rupture; Material Rupture
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. THE BALLOON RUPTURED. THE DEVICE WAS DISCARDED AT THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15056588 ↗MalfunctionJun 11, 2020Material Rupture; Material Rupture
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR TREATMENT. DURING INFLATION THE BALLOON RUPTURED AT 6 ATM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10144736 ↗
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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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