Passeo-14 2.5/140/150Recalls & reported problems
Biotronik AG · Class 2
All models of Passeo-14 (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07640130433755), received between Mar 11, 2021 and Jun 14, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE PASSEO-14 BALLOON CATHETER WAS CHOSEN FOR PTA OF A LOWER LEG BLOOD VESSEL. IT WAS REPORTED THAT THE GUIDEWIRE (NO FURTHER INFORMATION AVAILABLE) CAME OUT OF THE SIDE PORT INSTEAD OUT OF THE GUIDEWIRE LUMEN OF THE COMPLAINT INSTRUMENT. THUS, A CONNECTION BETWEEN THE GUIDEWIRE LUMEN AND THE INFLATION LUMEN WAS SUSPECTED. THIS WAS NOTED AFTER USING THE BALLOON SEVERAL TIMES WHEN THE DISTAL PORTION OF THE GUIDEWIRE WAS STILL INSIDE THE PATIENTS BODY WHILE THE DEFECTIVE PART OF THE INSTRUMENT WAS OUTSIDE OF THE PATIENTS BODY. DURING THE PREPARATIONS FOR THE INTERVENTION, THE COMPLAINT INSTRUMENT COULD BE NORMALLY FLUSHED. THE PASSEO-14 WAS USED AS USUAL IN A STANDARD WAY AND NO HIGH PRESSURE DEVICE WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17128274 ↗MalfunctionMar 11, 2021Inflation Problem; Inflation Problem
THE PASSEO-14 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE). THE DEVICE WAS DELIVERED TO THE LESION BUT THE BALLOON COULD NOT BE INFLATED. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO FINISH THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11467157 ↗
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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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