Oscar 3.0/20-180/127Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640130455795), received between Mar 14, 2023 and Feb 17, 2026 — classified as 3 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Fracture

  AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR TREATMENT OF THE POSTERIOR TIBIAL ARTERY. BY PUSHING AGAINST A CALCIFIED STENOSIS (BTK), THE OUTER CATHETER BROKE AT THE HUB-CONNECTION. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363664 ↗
• MalfunctionJan 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED CTO IN THE MID-SECTION OF THE ANTERIOR TIBIAL ARTERY. A 200CM V-14 GUIDE WIRE WAS USED IN COMBINATION WITH THE OSCAR. FIRST INFLATION WITH 8BAR COULD BE SUCCESSFULLY PERFORMED. DURING THE ATTEMPT TO ADVANCE THE GUIDE WIRE FURTHER DISTAL, THE WIRE LOOPED, AND THE OSCAR PTA WAS PUSHED FORWARD. GUIDE WIRE GOT DAMAGED AND SHOWED A WRINKLING AT THE DISTAL END. IT WAS NOT POSSIBLE TO REMOVE THE GUIDEWIRE THROUGH THE OSCAR PTA. THEREFORE, WIRE WAS REMOVED TOGETHER WITH OSCAR PTA. THE HYDROPHILIC COATING OF THE WIRE AT THE DISTAL END WAS PEELED OFF AND CREATED THE WRINKLING. A NEW WIRE WAS INTRODUCED INTO THE ALREADY USED OSCAR PTA AND INTRODUCED INTO THE PATIENT. DURING THE SECOND ATTEMPT OF INFLATION, IT WAS NOTICED THAT THE OSCAR PTA BALLOON LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489686 ↗
• MalfunctionMar 14, 2023Failure to Advance; Failure to Advance

  OSCAR 3/20-180/139 - AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR TREATMENT. IT WAS NOT POSSIBLE TO DELIVER THE OSCAR DEVICE. IT WAS NOT POSSIBLE TO PUSH FORWARD WITH DILATOR. THEREFORE, EXCHANGE FOR OSCAR PTA, WHICH WAS ABLE TO CROSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541656 ↗