St. Jude Medical, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2718-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 29, 2014

Date Posted: October 8, 2014

Recall Number: Z-2718-2014

Event ID: 69025

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.

Status: Terminated

Product Quantity: 2 units

Code Information:

Material 100077113, Batch 4558337

Distribution Pattern:

Distributed in the states of Texas and Illinois.

Voluntary or Mandated:

Voluntary: Firm initiated