FDAFDA · Food and drugs·Recall number Z-1959-2012
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.
Published July 18, 2012 · Recall initiated: June 18, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardiovascular Systems, Inc.
- Distributor
- Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.
- Lot
- Lot s: 59887, 59888, 61516, and 61517.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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