Oscar 4.0/20-180/128Recalls & reported problems
Biotronik AG · Class 2
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 07640130455771), received between Jul 18, 2023 and Jul 18, 2023 — classified as 1 malfunction.
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
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.
MalfunctionJul 18, 2023Fluid/Blood Leak; Fluid/Blood Leak
EVENT OCCURRED WHILE USING OSCAR ATTEMPTING A CTO LESION IN THE SFA. STOPCOCK ON SIDE SUPPORT WAS LEFT OPEN AND BLEED BACK WAS NOTICED. WHEN ASPIRATING AND FLUSHING, AIR WAS NOTICED IN THE SYSTEM. TUOHY WAS CHECKED AND WAS TIGHT AND LOCKING COLLAR WAS IN LOCK POSITION. SYSTEM WAS THEN REMOVED FROM PATIENT. SYSTEM WAS FLUSHED AND WHILE FLUSHING, FLUID WAS NOTICED COMING OUT BEHIND THE WHITE TIP CONTROL BARREL. APPARENTLY, THERE IS A CRACK OR FAULTY PIECE IN THE SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17347625 ↗
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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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