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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Event Detail

Event ID 62406
Product Type Devices
Status Ongoing
Recalling Firm Cardiovascular Systems, Inc.
City Saint Paul
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-18
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot s: 59887, 59888, 61516, and 61517. Class II 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. 27 Z-1959-2012
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