FDA Device recall Z-2124-2020
Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutan…
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutan… by Boston Scientific Neuromodulation, citing 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"….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2124-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-24 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Boston Scientific Neuromodulation |
| Distribution | n/a |
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
Reason
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.
Identifiers
| code_info | Part number M365SC3138550; serial numbers 1044463, 1066242, 3003060, 1044464, 1068589, 3006620, 1044466, 1068602, 3009…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2124-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.