FDA Medical Device Recalls (openFDA)
Boston Scientific Neuromodulation Corporation: 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.
- Recall number
- Z-2125-2020
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- 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.
- Status
- Terminated
- Initiated
- 2019-04-24
- Posted
- not on file
- Terminated
- 2022-01-18
- 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.
- Root cause
- 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
- 8 units
- Distribution
- Distributed OUS only. to 14 countries.
- Lot, serial or model codes
- Part number M365NM3138550; serial numbers 1049357, 1057232, 3014616, 1053194, 3010769, 3014631, 1057225 and 3012324.
- 510(k) numbers
- not on file
- PMA numbers
- ["P150031"]
- Product code
- NHL
- Firm FEI
- 3006630150
- Firm city
- Valencia
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28