FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1780-2010
- Recalling firm
- St. Jude Medical Atrial Fibrillation Division Inc
- 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
- Status
- Terminated
- Initiated
- 2009-06-15
- Posted
- 2010-06-07
- Terminated
- 2012-03-02
- 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 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
- 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
- Lot, serial or model codes
- Products with a serial number lower than 93859.
- 510(k) numbers
- ["K080292"]
- PMA numbers
- not on file
- Product code
- OCL
- Firm FEI
- 2938836
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28