Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145

FDA Recall Z-2385-2021 · 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.

↑