Boston Scientific Neuromodulation Corporation: Medical Device Recall in 2020 - (Recall #: Z-2120-2020)

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:

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.

Product Classification:

Class II

Date Initiated: April 24, 2019

Date Posted: June 3, 2020

Recall Number: Z-2120-2020

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: 19 units

Code Information:

Part number M365SC3138350; serial numbers 1041034, 1055172, 3000549, 1041380, 1056806, 3000564, 1053375, 1058008, 3001907, 1053695, 1058015, 3007457, 1053700, 1058017, 3008119, 1054299, 1062660, 1054304, and 1064590.

Distribution Pattern:

Distributed OUS only. to 14 countries.

Voluntary or Mandated:

Voluntary: Firm initiated