Z-2718-2014Class II

Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical...

Name: Z-2718-2014 Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical...
Creator: St. Jude Medical, Inc.
Published: 2014-07-29
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-07-29 / Terminated / root cause: packaging

FDA source

St. Jude Medical, Inc. began a recall of Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord... on 2014-07-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2718-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-29
Posted: 2014-09-29
Terminated: 2015-08-21
Recalling firm: Abbott Medical
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.
Product code: GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: A field action was initiated with customer letters, dated July 29, 2014, and attached replacement DFUs. The letter identified the affected product and the reason for the recall. The recalling firm requested the consignees refer to the replacement DFU for guidance while using the device, and to discard the international manuals. Questions regarding the letter should be directed to customers' St. Jude Neuromodulation Representative or call the Technical Services Department at 1-800-727-7846.
Quantity in commerce: 2 units
Distribution: Distributed in the states of Texas and Illinois.
Product codes and lots: Material 100077113, Batch 4558337

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2718-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2718-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-29
Z-2719-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-08	2014-09-29

Product code GZB

K123299Class IIMts System, Wide-Space Quattrode Percutaneous LeadsSt. Jude Medical Neuromodulation / cleared 2013-01-18

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)