Boston Scientific Neuromodulation Corporation: Medical Device Recall in 2020 - (Recall #: Z-2125-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 24, 2019

Date Posted: June 3, 2020

Recall Number: Z-2125-2020

Event ID: 84983

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.

Status: Terminated

Product Quantity: 8 units

Code Information:

Part number M365NM3138550; serial numbers 1049357, 1057232, 3014616, 1053194, 3010769, 3014631, 1057225 and 3012324.

Distribution Pattern:

Distributed OUS only. to 14 countries.

Voluntary or Mandated:

Voluntary: Firm initiated