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Na Sc-6386

by Boston Scientific Neuromodulation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08714729996712 UDI-DI Date28 Dec 2020ListedStatusListed GUDID: in commercial distribution

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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Active implantable device control magnet
Model / Reference
SC-6386
Primary DI / UDI-DI
08714729996712
PMA Number
FDA Product Code
QRB, LGW
GMDN Term
Active implantable device control magnet
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Active implantable device control magnet

Cleared under the same submission (P030017)

Show all (12)

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No