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.
FDA Recall Z-2718-2014 · Posted 2014-09-29
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Recalling FirmSt. Jude Medical, Inc.
Recall StatusTerminated
Product CodeGZB
Date Initiated2014-07-29
Date Terminated2015-08-21
Product Quantity2 units
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.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Distributed in the states of Texas and Illinois.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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