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

FDA device recall Z-2955-2011 · posted 2011-08-05 · Terminated

Recall details

Recalling firm

St. Jude Medical

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.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

IKD

Quantity affected

32

Distribution

Nationwide Distribution-USA (nationwide) including the states of FL, NC, NY, and OR.

Date initiated

2011-06-01

Date posted

2011-08-05

Date terminated

2012-08-16

Location

Minnetonka, MN