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U.S. Department of Health and Human Services

Class 2 Device Recall Stealth 360degree Obital Atherectomy Device

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  Class 2 Device Recall Stealth 360degree Obital Atherectomy Device see related information
Date Initiated by Firm June 18, 2012
Date Posted July 09, 2012
Recall Status1 Terminated 3 on July 19, 2012
Recall Number Z-1959-2012
Recall Event ID 62406
510(K)Number K110389  
Product Classification Catheter, peripheral, atherectomy - Product Code MCW
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.
Code Information Lot s: 59887, 59888, 61516, and 61517.
Recalling Firm/
Manufacturer		 Cardiovascular Systems, Inc.
651 Campus Dr
Saint Paul MN 55112-3495
For Additional Information Contact Megan Brandt
651-259-2805
Manufacturer 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 2		 Employee error
Action 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.
Quantity in Commerce 27
Distribution Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MCW and Original Applicant = CARDIOVASCULAR SYSTEMS, INC.
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