Fifty-five — Class II medical device recall Z-2124-2020
Terminated recall by Boston Scientific Neuromodulation Corporation, reported 2020-06-03. The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters
| Recall number | Z-2124-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Neuromodulation Corporation, Valencia, CA, United States |
| Recall initiated | 2019-04-24 |
| Classified | 2020-05-26 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2022-01-18 |
| Quantity | 41 units |
| Reason classes | labeling |
| Serial numbers | 1044463, 1044464, 1044466, 1061554, 1062766, 1062770, 1062787, 1063430, 1063632, 1063650, 1063749, 1063798, 1063801, 1066182, 1066242, 1068589, 1068602, 1068606, 1068608, 1068611, 3001046, 3002547, 3002561, 3002817, 3003040 and 16 more |
| Model numbers | M365SC3138550 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2124-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.