Z-1959-2012Class II

CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S...

Name: Z-1959-2012 CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S...
Creator: Cardiovascular Systems, Inc.
Published: 2012-06-18
License: https://open.fda.gov/license/

Cardiovascular Systems Incorporated / initiated 2012-06-18 / Terminated / root cause: manufacturing process

FDA source

Cardiovascular Systems, Inc. began a recall of CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth... on 2012-06-18. FDA classified it as Class II and gives the reason as "CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the...". 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-1959-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-18
Posted: 2012-07-09
Terminated: 2012-07-19
Recalling firm: Cardiovascular Systems Incorporated
Product: CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
Product code: MCW Catheter, Peripheral, Atherectomy
Reason for recall: CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Phone calls to affected sites began June 15, 2012 to quarantine the product. These same sites were also notified with an Urgent Medical Device Recall letter, dated June 18, 2012, via FedEx and e-mail (where available) on June 18, 2012. The letter notified each customer to remove from use and return the recalled product. The customer was instructed to complete a Customer Acknowledgement Form and return it with the device(s) being returned in the Returned Goods Authorization kit provided. Customers with questions can contact customer service at 1-877-274-0901. For any questions regarding this recall call 651-259-2805.
Quantity in commerce: 27
Distribution: Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.
Product codes and lots: Lot s: 59887, 59888, 61516, and 61517.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1959-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1959-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09

Product code MCW

K110389Class IIStealth 360 Orbital Pad SystemCardiovascular Systems, Inc. / cleared 2011-03-11

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)