Stealth RAD-SC30-175 (REF 7-10059-07)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10850000491325), received between Aug 9, 2023 and Nov 15, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated at the User Facility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Entrapment of Device; Material Separation; Device Contaminated at the User Facility; Entrapment of Device; Material Separation; Device Contaminated at the User Facility

  IT WAS REPORTED A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS USED TO TREAT A HEAVILY CALCIFIED, 90% STENOSED POPLITEAL ARTERY. DURING THE PROCEDURE, THE OAD CROWN BECAME STUCK IN THE SMALL BRANCH OF THE POPLITEAL ARTERY. IT WAS INDICATED THE VESSEL WAS TOO SMALL FOR THE OAD CROWN, WHICH LED TO THE OAD CROWN BECOMING STUCK. THE PHYSICIAN CHANGED ACCESS FROM THE LEFT RADIAL TO THE RIGHT FEMORAL. NITROGLYCERIN AND VERAPAMIL WERE ADMINISTERED, FOLLOWED BY BALLOON ANGIOPLASTY TO COMPLETE THE PROCEDURE. IT WAS INDICATED TISSUE WAS OBSERVED ON THE DEVICE EX-VIVO. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE OAD CROWN DETACHED. NO COMPONENTS WERE LEFT IN-VIVO.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20696536 ↗
• MalfunctionAug 9, 2023Device Contamination with Body Fluid; Device Contamination with Body Fluid

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR SIX TREATMENTS. AFTER THE TREATMENTS, IT WAS NOTICED THAT THE AMOUNT OF VIPERSLIDE IN THE BAG WAS NOT DECREASING DESPITE A LOT OF FLUSHING. BLOOD WAS OBSERVED IN THE SALINE TUBING. THE TREATMENT WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17487856 ↗