Enforcement Report - Week of July 18, 2012
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Product Detail
| 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. |
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| Recall Number | Z-1959-2012 |
| Classification | Class II |
| Code Info | Lot s: 59887, 59888, 61516, and 61517. |
| Product Distributed Qty | 27 |
| 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. |
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. |
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