Recall Z-2718-2014— St. Jude Medical, Inc.

Name: FDA recall Z-2718-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-29

Class II · Terminated

Class II FDA medical device recall by St. Jude Medical, Inc., initiated 2014-07-29, terminated 2015-08-21. It names one FDA 510(k) clearance: K123299. Product: Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.. Reason: The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals..

Recalling firm: St. Jude Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-07-29
Terminated: 2015-08-21
Firm location: Plano, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K123299 — MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADSSt. Jude Medical Neuromodulation·cleared 2013-01-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.

Reason for recall

The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.

Data sourced from openFDA. This site is unofficial and independent of the FDA.