St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide. Single-use
FDA device recall Z-1780-2010 · posted 2010-06-07 · Terminated
Recall details
- Recalling firm
- St. Jude Medical Atrial Fibrillation Division Inc
- 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
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- OCL
- Quantity affected
- 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, Singapor
- Date initiated
- 2009-06-15
- Date posted
- 2010-06-07
- Date terminated
- 2012-03-02
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EPICOR ABLATION SYSTEM (K080292) | St Jude Medical | 2008-07-25 |