Oscar PTA 2.0/20-180/127Recalls & reported problems
Biotronik AG · Class 2
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 07640130455702), received between Jan 4, 2023 and Sep 15, 2023 — classified as 2 malfunctions.
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 Rupture1
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.
MalfunctionSep 15, 2023Material Rupture; Material Rupture
AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO) OF THE ARTERIA TIBIALIS POSTERIOR (ATP) AND ARTERIA FIBULARIS. THE VESSEL WAS SEVERELY CALCIFIED. THE BALLOON RUPTURED DURING INTERVENTION AND WAS WITHDRAWN. NO PARTS REMAINED IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17755477 ↗MalfunctionJan 4, 2023Failure to Advance; Failure to Advance
AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED CHRONIC TOTAL OCCLUSION. THE OSCAR-PTA 2/20-180/139 DID NOT CROSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16096188 ↗
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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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