Z-2955-2011

Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters, Sterile EO, Rx only...

Name: Z-2955-2011 Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters, Sterile EO, Rx only...
Creator: St. Jude Medical
Published: 2011-06-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-06-01 / Terminated / root cause: labeling and UDI

FDA source

St. Jude Medical began a recall of Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters, Sterile EO, Rx only, St Jude Medical, 14901 DeVeau Place, Minnetonka... on 2011-06-01. The reason FDA records is "St. Jude Medical is recalling a single lot (3334664) of Supreme Electrophysiology Extension Cable which were packaged with a Quadripolar cable instead of a hexapolar Cable. St. Jude Medical has determined that the...". 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-2955-2011
Status: Terminated
Initiated: 2011-06-01
Posted: 2011-08-05
Terminated: 2012-08-16
Recalling firm: Abbott Medical
Product: Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters, Sterile EO, Rx only, St Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55345. Supreme Electrophysiology Extension Cable used to connect Electrophysiology catheters to external diagnostic or therapeutic equipment. The section indexing connector located a t the distal end of the cable will only connect to SMJ Electrophysiology catheters.
Product code: IKD Cable, Electrode
Reason for recall: St. Jude Medical is recalling a single lot (3334664) of Supreme Electrophysiology Extension Cable which were packaged with a Quadripolar cable instead of a hexapolar Cable. St. Jude Medical has determined that the incorrectly labeled product poses no safety risk since the extension cable can be safely used with a corresponding Quadripolar catheter but cannot be incorrectly connected to a Hexapolar catheter.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: St. Jude Medical sent an "IMPORTANT MEDICAL DEVICE FIELD ADVISORY NOTICE" letter dated June 8, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to locate the affected product and to complete and return an attached SJM AFD Reconciliation Form. The form will be used to replace product and as documentation that the customers received the notice. Fax the completed form to 877-497-031. Contact the Director of Product Marketing at 512-329-1054 for questions regarding this notice.
Quantity in commerce: 32
Distribution: Nationwide Distribution-USA (nationwide) including the states of FL, NC, NY, and OR.
Product codes and lots: Batch # 3334664

Product code IKD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)