Passeo-18 4/40/130Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640119559056), received between Oct 14, 2020 and Aug 26, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (2 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 Rupture2
- Fracture1
Patient problems
- Foreign Body Embolism1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2022Fracture; Material Rupture; Fracture; Material Rupture
A PASSEO-18 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF THE PERONEAL ARTERY. THE DEVICE WAS INSERTED AND DURING INFLATION THE BALLOON RUPTURED. DURING WITHDRAWAL THE INNER SHAFT OF THE BALLOON FRACTURED. THE RUPTURED BALLOON REMAINED IN THE ARTERY TOGETHER WITH THE INNER SHAFT. A STENT WAS ADVANCED, AND THE DISTAL FRACTURED PART OF THE BALLOON CATHETER WAS ADAPTED TO THE VESSEL WALL WITH A STENT. THERE WAS ONLY MINIMAL FLOW IN THE PERONEAL ARTERY. HOWEVER, THE PROCEDURE WAS STOPPED AT THIS POINT.
Patient problems: Foreign Body Embolism
MAUDE report 15301252 ↗MalfunctionOct 14, 2020Material Rupture; Material Rupture
A PASSEO-18 BALLOON CATHETER WAS CHOSEN FOR THE TREATMENT OF A MILDLY CALCIFIED LESION. THE BALLOON RUPTURED AT 5 ATM. THE BALLOON COULD BE WITHDRAWN AND ANOTHER BALLOON WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10681228 ↗
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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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