Events

Recall of Device Recall SJM Confirm, Implantable Cardiac Monitor (ICM)

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

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
    58686
  • Event Risk Class
    Class 2
  • Event Number
    Z-2733-2011
  • Event Initiated Date
    2011-03-31
  • Event Date Posted
    2011-07-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99926
  • 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 Cardiac Monitor (without arrythmia detection) - Product Code MXC
  • Reason
    The recall was initiated because st. jude medical made new software available for the sjm confirm dm2100 implantable cardiac monitor (icm) that incorporates enhancements to the devices sensing algorithm. these enhancements are intended to provide improved sensitivity and specificity for diagnosing arrhythmias. the user is presented with the option to upgrade new software into the sjm confirm icm.
  • Action
    St. Jude Cardiac Rhythm Management Division sent an "Important Product Correction" letter on March 25, 2011 to all affected customers. The letter explains the reason for the recall and provided recommendations including a software upgrade by SJM Field Clinical Engineer or Technical Services. Customers were recommended to fill out and return a "Physician Acknowledgement Form". For additional information please contact your local St.Jude Medical Sales Representative, Field Clinical Engineer or the Technical Services Department at 800-722-3774

Device

Device Recall SJM Confirm, Implantable Cardiac Monitor (ICM)
  • Model / Serial
    Confirm DM2100, DM2102 (IDE). Software Version 10.1.1.2
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: (USA) Nationwide including the States of CA, WA, FL, WV, NY, MD and LA, and the country of Germany
  • Product Description
    SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). || This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia
  • Manufacturer
    St Jude Medical CRMD

Manufacturer

St Jude Medical CRMD
  • Manufacturer Address
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA