Events

Recall of Device Recall Vector Selector Cable Switch

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Remington Medical Inc..

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
    33490
  • Event Risk Class
    Class 2
  • Event Number
    Z-0124-06
  • Event Initiated Date
    2005-08-31
  • Event Date Posted
    2005-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41953
  • 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
    Tester, Pacemaker Electrode Function - Product Code DTA
  • Reason
    The vector selector has an electrical design flaw which prevents rv pacing.
  • Action
    Guidant Corporation notified Remington Medical of the problem. Remington had instructed Guidant to retrieve the product from their sales force by 09/07/2005 and return to Remington by 09/09/2005.

Device

Device Recall Vector Selector Cable Switch
  • Model / Serial
    Lot number: 051781, 051782, 051783, 051788, 0517939.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MN
  • Product Description
    Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile * Manufactured by Remington Medical Incorporated, 6830 Meadowridge Court, Alpharetta, GA 30005, (770) 888-8520 or (800) 999-0057 * Distributed By: Guidant Corporation, 4100 Hamine Avenue North, St. Paul, MN 55112-5798 USA.
  • Manufacturer
    Remington Medical Inc.

Manufacturer

Remington Medical Inc.
  • Manufacturer Address
    Remington Medical Inc., 6830 Meadowridge Ct, Alpharetta GA 30005-2202
  • Source
    USFDA