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Terminated

STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO

FDA Recall Z-2386-2021 · Posted None

Recalling FirmCardiovascular Systems Inc
Recall StatusTerminated
Product CodeMCW
Date Initiated2021-07-21
Date Terminated2026-03-18
Product Quantity8 units

Reason for Recall

There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.

Firm Action

The firm notified its consignees by letter on 07/1/2021. The notice explained the issue and requested the return of the affected products.

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K190634Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. · 2019-07-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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