Fifty-five — Class II medical device recall Z-2125-2020

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-2125-2020`
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	8 units
Reason classes	labeling
Serial numbers	`1049357`, `1053194`, `1057225`, `1057232`, `3010769`, `3012324`, `3014616`, `3014631`
Model numbers	`M365NM3138550`

Product

Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive Parkinson s disease (PD) that are not adequately controlled with medication.

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-2125-2020. 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.