Z-0946-2009

Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation...

Name: Z-0946-2009 Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation...
Creator: St. Jude Medical Inc
Published: 2008-12-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-12-09 / Terminated

FDA source

St. Jude Medical Inc began a recall of Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical... on 2008-12-09. The reason FDA records is "Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0946-2009
Status: Terminated
Initiated: 2008-12-09
Posted: 2009-01-30
Terminated: 2010-12-28
Recalling firm: Abbott Medical
Product: Epicor LP Connecting Cable, CC-6-LP-CE, Catalog Number 12263, an accessory to the Epicor Cardiac Ablation Control System, manufactured by St.Jude Medical, Sunnyvale, CA Disposable connecting cable, accessory to the Epicor Cardiac Ablation Control System. The cable is used to connect the Epicor disposable tissue device (UltraCinch or UltraWand) to the Epicor Cardiac Ablation control System.
Product code: OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Reason for recall: Firm has received multiple reports of difficulties connecting the product and/or the presence of error code messages occurring with the use of the connecting cable and the Ablation Control System unit.
FDA root cause: Other
Action: The firm issued notification by "Urgent Product Recall" letter dated 12/4/2008, to all consignees. The letter describes the issue, potential risk and states that the product should be returned. For additional information, contact St Jude Medical at 800-722-3423.
Quantity in commerce: 158 units distributed.
Distribution: Worldwide - NY, IN, NC, UT, OR, CA, IL, MI, TX, TN, and FL and country of Belgium.
Product codes and lots: All serial numbers affected, lot numbers 08051201, 08051504, 08052202, 08062605, 08070702, 08070704, 08071604, 08071801, 08072505, 08072506, 08080119, 08080801, 08082702, 08091112, 08092210, 08092608, 08100202, 08100703, 08101005, 08102006, 08102325, 08102805, 08110530, and 08111412. ***UPDATE 01/09/2009*** Serial numbers NS-10156, NS-10158, NS-10159, NS-10160 and NS-10161 were originally not included in the original submission. The lot number assigned to prior SN assignment adds 08052901, 08081801, 08091801, 08040701, 08071806, 08101326, and 08103001

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)