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Stealth RAD-SC30-150 (REF 7-10058-02)Recalls & reported problems

Cardiovascular Systems, Inc. · Stealth, Radial Access OAD, 1.50mm, 10mm, 200cm shaft · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10852528005763), received between Oct 12, 2018 and Oct 12, 2018 — classified as 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Stroke/CVA1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT COMPLAINED OF BLURRED VISION THE DAY AFTER AN UNREMARKABLE ATHERECTOMY PROCEDURE WITH A DIAMONDBACK PERIPHERAL RADIAL ACCESS ORBITAL ATHERECTOMY DEVICE. THE PHYSICIAN STATED HE DOES NOT BELIEVE THE COMPLICATION WAS THE FAULT OF THE DEVICE AND WAS LIKELY DUE TO SPECIFIC PROCEDURAL MANIPULATIONS AND VASCULAR CHARACTERISTICS UNIQUE TO THE PATIENT. THE PATIENT WAS DIAGNOSED WITH A STROKE IN THE CLINIC AND WAS SCHEDULED FOR FOLLOW UP WITH A NEUROLOGIST. A POST-PROCEDURAL EMBOLIC STROKE EVENT WAS CONFIRMED RADIOGRAPHICALLY BY THE CONSULTING NEUROLOGIST. THE PATIENT'S SYMPTOMS APPEARED TO HAVE RESOLVED COMPLETELY.

    Patient problems: Stroke/CVA

    MAUDE report 7962357 ↗

Other Catheter, Peripheral, Atherectomy devices

All Catheter, Peripheral, Atherectomy devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.