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.
This recall has been terminated (originally issued July 9, 2012).
- Company
- Cardiovascular Systems Inc
- Recall Initiated
- June 18, 2012
- Posted
- July 9, 2012
- Terminated
- July 19, 2012
- Recall Number
- Z-1959-2012
- Quantity
- 27
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.
Lot / Code Info
Lot s: 59887, 59888, 61516, and 61517.
Root Cause
Employee error
Action Taken
Phone calls to affected sites began June 15, 2012 to quarantine the product. These same sites were also notified with an Urgent Medical Device Recall letter, dated June 18, 2012, via FedEx and e-mail (where available) on June 18, 2012. The letter notified each customer to remove from use and return the recalled product. The customer was instructed to complete a Customer Acknowledgement Form and return it with the device(s) being returned in the Returned Goods Authorization kit provided. Customers with questions can contact customer service at 1-877-274-0901. For any questions regarding this recall call 651-259-2805.