Thirty-five — Class II medical device recall Z-2120-2020
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-2120-2020 |
|---|---|
| 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 | 19 units |
| Reason classes | labeling |
| Serial numbers | 1041034, 1041380, 1053375, 1053695, 1053700, 1054299, 1054304, 1055172, 1056806, 1058008, 1058015, 1058017, 1062660, 1064590, 3000549, 3000564, 3001907, 3007457, 3008119 |
| Model numbers | M365SC3138350 |
Product
Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. 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 Product Usage: Contact extension kits are part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic intractable pain of the trunk and/or limbs. They are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation.
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-2120-2020. 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.