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U.S. Department of Health and Human Services

Class 2 Device Recall None

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  Class 2 Device Recall None see related information
Date Initiated by Firm April 24, 2019
Create Date May 26, 2020
Recall Status1 Terminated 3 on January 18, 2022
Recall Number Z-2124-2020
Recall Event ID 84983
PMA Number P030017 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage:
Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted.
Package Contents:
Lead Extension Kit
(1) Lead Extension
(1) Hex Wrench
(1) Tunneling Tool Assembly
(1) Device Registration Form/Temporary Patient Identification Card
(1) Manual

Code Information Part number M365SC3138550; serial numbers 1044463, 1066242, 3003060, 1044464, 1068589, 3006620, 1044466, 1068602, 3009041, 1061554, 1068606, 3009045, 1062766, 1068608, 3009050, 1062770, 1068611, 3010114, 1062787, 3001046, 3012781, 1063430, 3002547, 3013204, 1063632, 3002561, 3013267, 1063650, 3002817, 3018105, 1063749, 3003040, 3018106, 1063798, 3003042, 3018866, 1063801, 3003047, 3036973, 1066182, and 3003048.
Recalling Firm/
Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia CA 91355-5004
For Additional Information Contact Nicole Pshon
Manufacturer Reason
for Recall
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
FDA Determined
Cause 2
Labeling Change Control
Action Customers to the user level are being notified of the recall via letter sent by DHL courier beginning on April 24, 2019. A third-party recalling company is not being used. The Urgent Medical Device Product Removal Letter instructs customers to immediately cease further distribution or use of any remaining product affected by this removal. Customers who identify any affected products within their inventory are instructed to segregate them immediately and return the product(s) to the recalling firm in accordance with enclosed instructions. Customers will receive replacements for all removed products returned to the manufacturer. Customers who are distributors are requested to notify any of their customers who have received the affected product(s). Recipients of the recall notice are requested to pass the notice to any healthcare professional from their organization who needs to be aware and to any organization where the potentially affected devices have been transferred, if appropriate. In addition, it is requested that customers provide the recalling firm with details of any affected devices that have been transferred to other organizations. Customers are requested to email or fax the Reply Verification Tracking Form to the BSC Field Action Center to BCSFieldActionCenter@bsci.com or by fax to 1-866-213-1806. Return of the RVTF is requested even if customers do not have any affected product to return.
Quantity in Commerce 41 units
Distribution Distributed OUS only. to 14 countries.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LGW and Original Applicant = Boston Scientific Corp.