Recall of Device Recall Medtronic Marquis VR

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc. Cardiac Rhythm Managment.

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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 Cardioverter Defibrillator (Non-Crt) - Product Code LWS
  • Reason
    Medtronic marquis family of icd and crt-d devices having batteries manufactured prior to december 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.
  • Action
    Medtronic Sales Representatives contacted affected physicians starting 02/10/05 to deliver an Important Patient Management Information. The letter recommended patient managment options including quarterly follow-ups, programming Patient Alert to 'On-High', provide magnet to patients to check device status and inform patients that should they expereicnce warmth in the area surrounding the ICD to seek prompt care.


  • Model / Serial
    Model 7230 Marquis VR (serial numbers listed include all affected devices but may include some unaffected devices. Patients are recommended to check with their doctor for exact serial numbers affected.) 7230B S-Series: PLW600001S - PLW600646S.  7230Cx H-Series: PKD100001H - PKD116584H, PKD117397H, PKD117553H, PKD117735H, and PKD117741H.  R-Series: PKD200084R - PKD200536R, PKD600016R - PKD600113R.  S-Series: PKD600009S - PKD608391S.  7230E S-Series: PLY600001S - PLY600749S and PLY600839S.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
  • Product Description
    Medtronic Marquis VR, model 7230 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.
  • Manufacturer


  • Manufacturer Address
    Medtronic Inc. Cardiac Rhythm Managment, 7000 Central Ave Ne, Fridley MN 55432
  • Source