Z-1780-2010

St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide...

Name: Z-1780-2010 St. Jude Medical Epicor UltraWand LP Handheld Ablation Device, model UW-LP-2, Sterilized with Ethylene Oxide...
Creator: St. Jude Medical Atrial Fibrillation Division Inc
Published: 2009-06-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-06-15 / Terminated / root cause: labeling and UDI

FDA source

St. Jude Medical Atrial Fibrillation Division Inc began a recall of 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... on 2009-06-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1780-2010
Status: Terminated
Initiated: 2009-06-15
Posted: 2010-06-07
Terminated: 2012-03-02
Recalling firm: Abbott Medical
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
Product code: OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
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
Root cause tag: labeling and UDI
FDA 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 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
Product codes and lots: Products with a serial number lower than 93859.

Product code OCL

K080292Class IIEpicor Ablation SystemSt Jude Medical / cleared 2008-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)