Device 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.
Z-1959-2012
Product summary
- Event
- Event 62406
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27
- Official record key
device-enforcement:Z-1959-2012
Official wording
Reason: 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.
Code information: Lot s: 59887, 59888, 61516, and 61517.
Distribution pattern: Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.
Derived failure modes
-
Unknown
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.