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Artisan™ SC-8216-50

by Boston Scientific Neuromodulation 2 variants

Artisan™ SC-8216-50 is a Class III device made by Boston Scientific Neuromodulation, approved under FDA PMA P030017 on 27 Apr 2004 and listed in FDA GUDID since 14 Dec 2015 (UDI-DI 08714729779902), active as of 23 Oct 2026. 17 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

PMA P030017

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08714729779902 UDI-DI Date14 Dec 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP030017 Date27 Apr 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P030017 decided 27 Apr 2004 Active
  • FDA GUDID UDI-DI 08714729779902 listed 14 Dec 2015 Listed

Recalls

17 recalls · 3 ongoing · FDA

    • Ongoing Z-2879-2026 FDA Class I initiated 17 Jun 2026

    Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.

    • Ongoing Z-2404-2026 FDA Class II initiated 29 Apr 2026

    Sterile anchors my lack sterility assurance.

    • Ongoing Z-2617-2024 FDA Class II initiated 17 Jul 2024

    Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.

  • 5 recalls, same reason

    • Terminated Z-2124-2020 FDA Class II initiated 24 Apr 2019
    • Terminated Z-2122-2020 FDA Class II initiated 24 Apr 2019
    • Terminated Z-2119-2020 FDA Class II initiated 24 Apr 2019
    • Terminated Z-2121-2020 FDA Class II initiated 24 Apr 2019
    • Terminated Z-2120-2020 FDA Class II initiated 24 Apr 2019

    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.

    • Terminated Z-2123-2020 FDA Class II initiated 24 Apr 2019

    The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to "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.

    • Terminated Z-1409-2010 FDA Unclassified (pre-2012) initiated 19 Mar 2010

    Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers. Based on Toshiba's investigation with Sony Corporation, they concluded that the battery cells in specific manufacturing lots could be affected.

    • Terminated Z-0271-2009 FDA Unclassified (pre-2012) initiated 22 Sep 2008

    Since April 2004, 27 of 8,769 (0.31%) patients have reported receiving second degree burns in the area of charging and 3 of 8,769 (0.03%) patients have reported receiving third degree burns in the area of charging while using Charger 1 .0. Some of these events were the direct result of the patient disregarding the instructions for use, such as sleeping with the Charger on or placing it directly on

    • Terminated Z-1441-2012 FDA Unclassified (pre-2012) initiated 22 Apr 2008

    The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual.

    • Terminated Z-0960-2008 FDA Unclassified (pre-2012) initiated 5 Oct 2007

    Incorrect Data -- Corruption of internal memory component results in an inability for the physician to reprogram the IPG with firmware version prior to Revision 3.02. When this occurs, the IPG will report an error code of "10h0" or "00h0" through the Remote Control. Under this condition, the IPG will cease to log in some data that could be used for informational purposes. ** It should be noted t

    • Terminated Z-0055-2008 FDA Unclassified (pre-2012) initiated 3 Aug 2007

    Mislabeled: Product labeled with the incorrect shelf-life information.

    • Terminated Z-0700-2007 FDA Unclassified (pre-2012) initiated 30 Jan 2007

    The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check.

    • Terminated Z-0299-2007 FDA Unclassified (pre-2012) initiated 21 Sep 2006

    A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient.

    • Terminated Z-0396-05 FDA Unclassified (pre-2012) initiated 11 Nov 2004

    A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.

Timeline

19 dated events

  1. Listed FDA GUDID 08714729779902
  2. Recall initiated FDA recalls Z-2124-2020
  3. Recall initiated FDA recalls Z-2122-2020
  4. Recall initiated FDA recalls Z-2119-2020
  5. Recall initiated FDA recalls Z-2123-2020
  6. Recall initiated FDA recalls Z-2121-2020
  7. Recall initiated FDA recalls Z-2120-2020
  8. Recall initiated FDA recalls Z-2617-2024
  9. Recall initiated FDA recalls Z-2404-2026
  10. Recall initiated FDA recalls Z-2879-2026

9 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
Artisan™
Generic name
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Model / reference
SC-8216-50
Primary DI / UDI-DI
08714729779902
PMA number
FDA product code
LGW, QRB
GMDN term
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
Device class
Class III
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

Cleared under the same submission (P030017)

and 8 more cleared under P030017

Similar devices

Other devices filed under FDA product code LGW (STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF).

Other devices from Boston Scientific Neuromodulation

See all devices from Boston Scientific Neuromodulation →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (8, all answered No)