Z-2119-2020Class II

ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One...

Name: Z-2119-2020 ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One...
Creator: Boston Scientific Neuromodulation Corporation
Published: 2019-04-24
License: https://open.fda.gov/license/

Boston Scientific Neuromodulation Corporation / initiated 2019-04-24 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Neuromodulation Corporation began a recall of 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... on 2019-04-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2119-2020
Classification: Class II
Status: Terminated
Initiated: 2019-04-24
Posted: 2020-05-26
Terminated: 2022-01-18
Recalling firm: Boston Scientific Neuromodulation Corporation
Product: 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 code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
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.
Root cause tag: labeling and UDI
FDA 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 [email protected] 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 in commerce: 2 units
Distribution: Distributed OUS only. to 14 countries.
Product codes and lots: Part number M365SC8216700; serial numbers 632107 and 645608

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2119-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2119-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-26
Z-2120-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-26
Z-2121-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-26
Z-2122-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-26
Z-2123-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-26
Z-2124-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-26
Z-2125-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-26

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)