Events

Recall of Device Recall Algovita Stimulator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by QiG Group LLC.

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
    73150
  • Event Risk Class
    Class 2
  • Event Number
    Z-1192-2016
  • Event Initiated Date
    2016-01-26
  • Event Date Posted
    2016-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143221
  • 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
    Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
  • Reason
    The implantable pulse generator (ipg) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5 cm). the following functions may not be available: reprogramming the stimulator, adjusting stimulation parameters (on/off, intensity modifications, stimulation program selection), and recharging the stimulator.
  • Action
    Consignee was sent on 1/26/2016 a Algostim, LLC "Urgent Field safety Notice" dated January 21, 2016. The letter described the problem and the product involved in the recall. The letter provided Background information as well as described the Clinical Implications, Rate of Occurrence, Recommendations and Mitigations. Advised consignee to deliver the respective letter to each physician who have implanted affected product and collect signed Response forms.

Device

Device Recall Algovita Stimulator
  • Model / Serial
    Serial Numbers: 03EDBF, 03EDC1, 03EDC5, 03EDC7, 03EDC9, 03EDCA, 03EDCE, 03EDD0, 03EDE5, 03EDE8, 03EDE9, 03EDEA, 03EDEF, 03EDF0, 03EE01, 03EE03, 03EE05, 03EE1C, 03EE1F, 03EE24, 03EE25, 03EE26, 03EE28, 03EE34, 03EE35, 03EE36, 03EE37, 03EE3A, 03EE3B, 03EE5A, 03EE5B, 03EE60, 03EE96, 03EE97, 03EE98, 03EE9D, 03EE9F, 03EEA2, 03EEA3, 03EEA4, 03EEAC.
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed in Germany and Luxembourg.
  • Product Description
    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
  • Manufacturer
    QiG Group LLC

Manufacturer

QiG Group LLC
  • Manufacturer Address
    QiG Group LLC, 10675 Naples St NE, Blaine MN 55449-5802
  • Manufacturer Parent Company (2017)
    QiG Group LLC
  • Source
    USFDA