Recall Z-1959-2012
Cardiovascular Systems, Inc. · initiated June 18, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot s: 59887, 59888, 61516, and 61517.
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.
FDA-determined 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.
Details
- Recall number
- Z-1959-2012
- Initiated
- June 18, 2012
- Posted by FDA
- July 9, 2012
- Terminated
- July 19, 2012
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Quantity
- 27
- Distribution
- Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.
- Recalling firm
- Cardiovascular Systems, Inc., Saint Paul, MN