Boston Scientific Neuromodulation Corporation: Medical Device Recall in 2020 - (Recall #: Z-2119-2020)

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:

ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1) Manual - Product Usage: The surgical paddle leads function as a component of Boston Scientific s spinal cord stimulator (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in a inhibition of pain sensation.

Product Classification:

Class II

Date Initiated: April 24, 2019

Date Posted: June 3, 2020

Recall Number: Z-2119-2020

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: 2 units

Code Information:

Part number M365SC8216700; serial numbers 632107 and 645608

Distribution Pattern:

Distributed OUS only. to 14 countries.

Voluntary or Mandated:

Voluntary: Firm initiated