Events

Recall of Precision Implantable Pulse Generator

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

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
    39383
  • Event Risk Class
    Class 2
  • Event Number
    Z-0055-2008
  • Event Initiated Date
    2007-08-03
  • Event Date Posted
    2007-10-12
  • 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=55506
  • 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
    Implantable Pulse Generator - Product Code LGW
  • Reason
    Mislabeled: product labeled with the incorrect shelf-life information.
  • Action
    There was one unit affected by this field action. An Advanced Bionics representative contacted and visited the facility on August 3, 2007. At this time, the affected device has been retrieved by the Company.

Device

Precision Implantable Pulse Generator
  • Model / Serial
    Model Number SC-1110, Serial Number 161767
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    MD
  • Product Description
    Precision Implantable Pulse Generator (IPG), Model Number SC-110
  • Manufacturer
    Advanced Bionics Corp

Manufacturer

Advanced Bionics Corp
  • Manufacturer Address
    Advanced Bionics Corp, 12740 San Fernando Rd, Sylmar CA 91342-3728
  • Source
    USFDA