Passeo-14 3/220/150Recalls & 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
- 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 07640130433885), received between Aug 31, 2021 and Aug 31, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation 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
- Deflation Problem1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2021Deflation Problem; Fracture; Deflation Problem; Fracture
THE PASSEO-14 BALLOON CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS ANTERIOR TIBIAL ARTERY. THE BALLOON WAS SLOW TO DEFLATE AFTER FIRST AND SECOND USE. WHEN BALLOON WAS BEING REMOVED FROM SHEATH ON NEGATIVE PRESSURE, IT GOT STUCK ABOUT 5CM OUT AND THE BALLOON BROKE AWAY FROM THE CATHETER/PROXIMAL CONNECTER. IT WAS STATED BY THE PHYSICIAN THAT IT STILL HAD CONTRAST IN IT AND HE BELIEVED THAT THE BALLOON WAS STILL INTACT. HE RELEASED THE PRESSURE AND PUT ON NEGATIVE AGAIN. AFTER WAITING FOR BUBBLES TO STOP, HE USED FORCE TO REMOVE BALLOON. THIS CAUSED PROXIMAL END OF THE BALLOON TO BREAK AWAY FROM SHAFT. NO DEVICE PART REMAINED IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12394694 ↗
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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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