Events

Recall of Advanced Bionics Precision Linear Leads

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Advanced Bionics Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    36624
  • Event Risk Class
    Class 2
  • Event Number
    Z-0299-2007
  • Event Initiated Date
    2006-09-21
  • Event Date Posted
    2007-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49022
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    spinal cord stimulation leads - Product Code LGW
  • Reason
    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.
  • Action
    In United States, the clinician recall notification letters were distributed by Fed-Ex or U.S. Postal Service certified mail on 09/21/2006. For the other regions, the in-country representatives started providing notification to the clinicians on 09/21/2006. The recall notification letters will instruct physicians to immediately return the unimplanted units.

Device

Advanced Bionics Precision Linear Leads
  • Model / Serial
    Serial Numbers: 111744, 112122, 112141, 112224, 112233, 114114, 116547, 116553, 117860, 117907, 110490, 100600, 110625, 110809, 113745, 113780, 112055 and 118943
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide.
  • Product Description
    Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70.
  • Manufacturer
    Advanced Bionics Corporation

Manufacturer

Advanced Bionics Corporation
  • Manufacturer Address
    Advanced Bionics Corporation, 12740 San Fernando Rd, Bldgs. 1 & 3, Sylmar CA 91342
  • Source
    USFDA