Recall Z-1780-2010 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
St. Jude Medical Atrial Fibrillation Division Inc
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
| Date | Jun 7, 2010 (initiated Jun 15, 2009) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080292 | EPICOR ABLATION SYSTEM St Jude Medical, Jul 25, 2008 |