Z-2386-2021Class II

Stealth 360 Gen2 Peripheral Orbital Atherectomy System, 1.25Mm Micro, 145 Cm, Ref Prd-Sc30-Micro

Name: Z-2386-2021 Stealth 360 Gen2 Peripheral Orbital Atherectomy System, 1.25Mm Micro, 145 Cm, Ref Prd-Sc30-Micro
Creator: Cardiovascular Systems Inc
Published: 2021-07-21
License: https://open.fda.gov/license/

Cardiovascular Systems Incorporated / initiated 2021-07-21 / Terminated / root cause: manufacturing process

FDA source

Cardiovascular Systems Inc began a recall of STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO on 2021-07-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2386-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-21
Posted: 2021-08-28
Terminated: 2026-03-18
Recalling firm: Cardiovascular Systems Incorporated
Product: Stealth 360 Gen2 Peripheral Orbital Atherectomy System, 1.25Mm Micro, 145 Cm, Ref Prd-Sc30-Micro
Product code: MCW Catheter, Peripheral, Atherectomy
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 8 units
Distribution: US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL
Product codes and lots: Lot 340931

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2386-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2385-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-08-28
Z-2386-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-08	2021-08-28

Product code MCW

K190634Class IIDiamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc. / cleared 2019-07-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)