Stealth RAD-SC30-150 (REF 7-10059-06)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10850000491318), received between Jun 10, 2021 and Jan 21, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2025Fluid/Blood Leak; Difficult to Insert; Fluid/Blood Leak; Difficult to Insert

  IT WAS REPORTED DURING THE PROCEDURE, THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS LEAKING FROM THE BASE AND THE VIPERWIRE GUIDE WIRE WAS UNABLE TO BE ADVANCED THROUGH THE OAD. A NEW OAD WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200613 ↗
• MalfunctionSep 19, 2024Difficult to Remove; Material Separation; Unexpected Shutdown; Difficult to Remove; Material Separation; Unexpected Shutdown

  THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT IN THE COMMON FEMORAL. THE OAD WAS SPUN ON LOW SPEED AND MEDIUM SPEED WITHOUT ISSUE. WHILE SPINNING THE OAD ON HIGH SPEED, THE OAD STALLED AND BECAME STUCK ON THE VIPERWIRE ADVANCE GUIDE WIRE. BOTH THE OAD AND VIPERWIRE WERE REMOVED TOGETHER. THE VESSEL WAS REWIRED WITH A NON-ABBOTT GUIDEWIRE AND ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED DURING DEVICE ANALYSIS THAT INDICATED THE DRIVESHAFT FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256082 ↗
• InjuryJun 10, 2021Mechanical Problem; Mechanical Problem

  A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED VIA LEFT RADIAL ACCESS TO SUCCESSFULLY TREAT LESIONS IN THE SUPERFICIAL FEMORAL, POPLITEAL, AND TIBIOPERONEAL TRUNK ARTERIES. THE OAD WAS ADVANCED TO THE ANTERIOR TIBIAL ARTERY AND TREATMENT WAS STARTED. THE OAD STOPPED SPINNING AND WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. DURING RECOVERY, THE PATIENT COMPLAINED OF FOOT PAIN UPON WAKING UP FROM SEDATION. ULTRASOUND WAS PERFORMED AND FLOW WAS CONFIRMED TO BE PRESENT. IT WAS DETERMINED THAT EXTRAVASATION HAD OCCURRED AND THE PATIENT WAS TRANSFERRED TO A HOSPITAL WHERE A FASCIOTOMY WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THIS PROCEDURE.

  Patient problems: Extravasation; Pain

  MAUDE report 11979025 ↗