Cardiovascular Systems, Inc.: Medical Device Recall in 2012 - (Recall #: Z-1959-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 18, 2012

Date Posted: July 18, 2012

Recall Number: Z-1959-2012

Event ID: 62406

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.

Status: Terminated

Product Quantity: 27

Code Information:

Lot s: 59887, 59888, 61516, and 61517.

Distribution Pattern:

Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated