Oscar PTA 6.0/20-180/128Recalls & 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 07640130455641), received between Jan 3, 2023 and Jan 3, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance1
- Material Deformation1
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.
MalfunctionJan 3, 2023Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR TREATMENT. THE OSCAR PTA 6/20-180/140 WAS STUCK IN THE CALCIFIED LESION (60 PERCENT STENOSIS DEGREE) IN THE POPLITEAL FEMORAL ARTERY, AND THE SUPPORT CATHETER DEVICE WAS KINKED. A PULSAR 6/100/135 WAS USED THROUGH THE SUPPORT CATHETER TO COMPLETE THE INTERVENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16087789 ↗
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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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