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Stealth RAD-SC30-125Recalls & reported problems

Cardiovascular Systems, Inc. · Stealth, Radial Access OAD, 1.25mm, 10mm, 200cm shaft · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10852528005756), received between Jan 14, 2019 and Jan 14, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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

Device problems

  • Infusion or Flow Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJan 14, 2019Infusion or Flow Problem; Infusion or Flow Problem

    FOLLOWING TREATMENT OF A CALCIFIED LESION WITH A CSI DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), THE SHAFT OF THE DEVICE WAS NOTED TO CONTAIN BLOOD. THE DEVICE WAS EXAMINED AND IT WAS VERIFIED THAT NO SALINE WAS FLOWING THROUGH THE SHAFT. IT IS UNKNOWN HOW LONG THE DEVICE WAS OPERATED WITHOUT SALINE FLOW. THERE WAS NO INJURY TO THE PATIENT REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8246224 ↗

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.