Boston Scientific Neuromodulation Corporation: Medical Device Recall in 2020 - (Recall #: Z-2122-2020)

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:

The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is 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. Package Contents Percutaneous Permanent Lead Kits (1) Percutaneous Lead with pre-loaded Curved Stylet (1) Stylet Ring with a Curved and a Straight Stylet (4) Suture Sleeves (1) Insertion Needle with Stylet (1) Lead Blank (1) Steering Cap (1) OR Cable Assembly (2) Lead Position Labelsleft and right (non-sterile) (1) Device Registration Form/Temporary Patient Identification Card (1) Manual

Product Classification:

Class II

Date Initiated: April 24, 2019

Date Posted: June 3, 2020

Recall Number: Z-2122-2020

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: 1 unit

Code Information:

Part number M365SC2352700; serial number 1042757.

Distribution Pattern:

Distributed OUS only. to 14 countries.

Voluntary or Mandated:

Voluntary: Firm initiated