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Class 2 Device Recall Epicor Ultra Wand LP Handheld Ablation Device |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
June 15, 2009 |
Date Posted |
June 07, 2010 |
Recall Status1 |
Terminated 3 on March 02, 2012 |
Recall Number |
Z-1780-2010 |
Recall Event ID |
53611 |
510(K)Number |
K080292
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Product Classification |
Surgical device, for ablation of cardiac tissue - Product Code OCL
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Product |
St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use. The Ultra Wand LP device is designed for use with the Epicor Cardiac Ablation System. St. Jude Medical 240 Santa Ana Court, Sunnyvale, CA 94085 USA |
Code Information |
Products with a serial number lower than 93859. |
Recalling Firm/ Manufacturer |
St. Jude Medical Atrial Fibrillation Division Inc 240 Santa Ana Ct Sunnyvale CA 94085-4512
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For Additional Information Contact |
408-733-6500 Ext. 301
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Manufacturer Reason for Recall |
The firm states that overheating of cardiac tissue is caused by inadequate cooling. The potential exists when the UltraWand is run using off-label cooling methods (gravity saline flow instead of pump) that cooling flow to one or both cells can be decreased based on pressure applied by the physician to the device. To reflect this information to the user, the Atrial Fibrillation Division (AFD) has
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FDA Determined Cause 2 |
Other |
Action |
St. Jude Medical issued a Market Bulletin, dated 06/15/2009, to their Field Representatives who were instructed to contact customers to make them aware that changes were made to the Instructions for Use (IFU) by SJM and that the customer may notice an extra IFU included in the shipping package. All such worldwide regulatory approvals will be needed before a revised IFU can eventually be included directly within the device package (as opposed to the shipping box). Existing instructional materials including the Epicor LP System Set-up ACS hang sheet and the EpicorLP In-service slides are being revised to reflect the UltraWand LP IFU changes The forthcoming Epicor LP In-service video is also being updated to reflect these changes. An Important Medical Device Safety Information letter, dated 11/06/2009 was sent via FedEx beginning 11/10/2009 to all US customers and will also shipped to all OUS customers beginning 11/13/2009. A copy of the new IFU will be sent with the letter which is being sent to all customers that have purchased or consigned the SJM UltraWand LP product since its commercial release in July of 2008. The customer notification includes the SJM Marketing managers and director for questions on the action. |
Quantity in Commerce |
1813 (1155 US, 658 OUS) |
Distribution |
AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. OUS to include Australia, Canada, Japan, Korea, Singapore |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = OCL and Original Applicant = ST. JUDE MEDICAL
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