Recall Z-2386-2021— Cardiovascular Systems Inc

Name: FDA recall Z-2386-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-21

Class II · Terminated

Class II FDA medical device recall by Cardiovascular Systems Inc, initiated 2021-07-21, terminated 2026-03-18. It names one FDA 510(k) clearance: K190634. Product: STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO. Reason: 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..

Recalling firm: Cardiovascular Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2021-07-21
Terminated: 2026-03-18
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K190634 — Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.·cleared 2019-07-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.