Oscar 2.0/20-180/127Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640130455597), received between Aug 10, 2023 and Mar 12, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2024Fracture; Fracture

  AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR REVASCULARIZATION OF A STAGE 4 POSTERIOR TIBIAL ARTERY. THE OSCAR DILATOR WAS MOVED TO THE TIBIAL FIBULAR TRUNK BUT WERE UNABLE TO BE MOVED ON THE WIRE. WHEN THE OSCAR BALLOON WAS INTRODUCED IN THE SUPPORT CATHETER, THE WHITE/BLUE HANDLE (LOCK GRIP) TOTALLY DISCONNECTED FROM THE CATHETER THEY THEN HAD TO RETRIEVE THE WHOLE SYSTEM AND CONTINUED THE PROCEDURE IN THE TRADITIONAL WAY WITH NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18890270 ↗
• MalfunctionFeb 22, 2024Fracture; Fracture

  AN OSCAR MULTIFUNCTIONAL CATHETER WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE ) IN THE MILDLY TORTUOUS POSTERIOR TIBIAL ARTERY. THE OSCAR BALLOON WAS PREPARED AS PER IFU AND INSERTED INTO THE OSCAR SUPPORT CATHETER. THE BALLOON WAS ADVANCED TO LESION AND INFLATED TO RBP TWO TIMES. IT WAS ATTEMPTED TO ADVANCE THE BALLOON FURTHER DISTALLY, BUT THE STENOSIS WAS VERY TIGHT. THE CONSTANT FORWARD PRESSURE ON THE BALLOON CAUSED THE HUB OF THE SUPPORT CATHETER TO FRACTURE FROM THE HUB OF THE OSCAR DEVICE. THE OSCAR WAS REMOVED AND SUBSEQUENTLY THE SUPPORT CATHETER AND BALLOON SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18759270 ↗
• MalfunctionFeb 8, 2024Fracture; Failure to Advance; Fracture; Failure to Advance

  THE OSCAR BALLOON SHAFT BROKE RIGHT AFTER THE METALLIC HUPOTUBE WHILE TRYING TO CROSS A SEVERELY CALCIFIED LESION AT THE DISTAL PTA. EXTREME FORCE WAS USED IN THE ATTEMPT TO CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669183 ↗
• MalfunctionAug 10, 2023Fracture; Fracture

  AN OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM WAS SELECTED FOR TREATMENT. EVENT OCCURRED WHILE USING OSCAR ATTEMPTING TO CROSS A LESION (100 PERCENT STENOSIS DEGREE) IN THE POSTERIOR TIBIAL ARTERY. A CONTRALATERAL APPROACH WAS USED, AND WHILE ADVANCING THE OSCAR SYSTEM THE PROXIMAL SHAFT FRACTURED. SYSTEM WAS THEN REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498944 ↗