Stealth RAD-SC30-175 (REF 7-10058-03)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10852528005770), received between Nov 26, 2019 and May 27, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Remains Activated” (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.

• InjuryMay 27, 2020Entrapment of Device; Entrapment of Device

  A STEALTH PERIPHERAL RADIAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT LESIONS IN THE SUPERFICIAL FEMORAL AND POSTERIOR TIBIAL ARTERIES WITH NO ISSUES. THE OAD WAS THEN ADVANCED TO TREAT A SMALL AND HEAVILY CALCIFIED AREA OF THE ANTERIOR TIBIAL ARTERY. ONE TREATMENT PASS WAS PERFORMED AT LOW SPEED, HOWEVER AS THE OAD WAS ADVANCED IT STOPPED SPINNING AND BECAME STUCK IN THE VESSEL. MULTIPLE TROUBLESHOOTING ATTEMPTS WERE PERFORMED, INCLUDING ADMINISTRATION OF NITROGLYCERIN, APPLICATION OF A WARM COMPRESS AND CREATION OF ALTERNATE ACCESS SITES, HOWEVER THE DEVICE WAS UNABLE TO BE RETRIEVED. THE PATIENT WAS TRANSFERRED TO A HOSPITAL AND A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE OAD. THE OAD WAS FOUND TO BE OUTSIDE OF THE VESSEL, RESULTING IN VESSEL LIGATION. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE SURGICAL PROCEDURE.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10093916 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TARGET LESION WAS IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS 100% STENOSED. SIX TREATMENT PASSES WERE PERFORMED WITH A PERIPHERAL STEALTH RADIAL ORBITAL ATHERECTOMY DEVICE (OAD) ON MEDIUM AND HIGH SPEEDS. BALLOON ANGIOPLASTY DILATATION WAS THEN PERFORMED, HOWEVER SIGNIFICANT RESIDUAL STENOSIS REMAINED. A SHORTER BALLOON AT HIGH PRESSURE WAS THEN USED TO PERFORM DILATATION IN THE MID SFA, FOLLOWING WHICH A TYPE C DISSECTION WAS NOTED. THE BALLOON WAS INFLATED IN PLACE AND ACCESS WAS GAINED TO THE POSTERIOR TIBIAL ARTERY. A SHEATH WAS INSERTED AND A STENT WAS DELIVERED. THE BALLOON WAS THEN USED TO DILATE THE STENT. THE FINAL ANGIOGRAM SHOWED EXCELLENT FLOW AND THE PATIENT WAS DISCHARGED THE SAME DAY.

  Patient problems: Vascular Dissection

  MAUDE report 9416286 ↗
• MalfunctionNov 26, 2019Device Remains Activated; Device Remains Activated

  DURING A PROCEDURE, THE STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) WAS OPERATED ON MEDIUM SPEED FOR ONE TREATMENT PASS. THE OAD WAS SWITCHED TO HIGH SPEED AND SOUNDED VERY LOUD AS THOUGH IT WERE INCREASING IN SPEED. AN ATTEMPT WAS MADE TO TURN OFF THE OAD USING THE POWER BUTTON, BUT IT WAS UNSUCCESSFUL, AND THE OAD CONTINUED SPINNING. THE SALINE PUMP WAS POWERED OFF, IN ORDER TO CEASE POWER TO THE OAD. THE OAD WAS REMOVED FROM THE SHEATH AND THE PUMP WAS POWERED BACK ON. THIS CAUSED THE OAD TO POWER BACK UP, AND THE SAME ISSUE RECURRED. THE DEVICE WAS REPLACED WITH A SECOND OAD TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9380427 ↗