Events

Recall of Device Recall Medtronic Carelink Monitor Model 2490C

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc. Cardiac Rhythm Disease 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
    Recall
  • Event ID
    56118
  • Event Risk Class
    Class 2
  • Event Number
    Z-2209-2010
  • Event Initiated Date
    2010-06-11
  • Event Date Posted
    2010-08-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92698
  • 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
    Pulse generator, permanent, implantable - Product Code NVZ
  • Reason
    Medtronic has identified that a subset of 2490c carelink monitors recently received an incorrect software update. patients reported that their monitor was making a "ticking sound" and they were unable to transmit device data via carelink. these monitors are now non-functional. no patient injuries have been reported as a result of this issue.
  • Action
    Starting on 6/11/2010, Medtronic began sending Australian and Canadian consignees "Medical Device Recall" letters dated 6/10/2010. The letters describe the problem and product involved. The letters instructs consignees to order replacement monitors, notify affected patients, and instruct each patient to perform a manual transmission upon receipt of the new monitor. Medtronic will provide affected patients with a prepaid return kit to faciliate the return of the monitor to Medtronic. Australian consignees should contact Scott Dunlop at 61-7 3025-3547. Canadian consignees should contact Medtronic Patient Services at 1-800-268-5346.

Device

Device Recall Medtronic Carelink Monitor Model 2490C
  • Model / Serial
    Lot Serial No IJX061043P IJX061063P IJX067150P IJX067158P IJX067162P IJX013664P IJX013831P IJX014701P IJX014899P IJX015305P IJX015406P IJX015768P IJX062594P IJX062607P IJX062654P IJX062655P IJX062656P IJX062661P IJX062669P IJX062670P IJX062672P IJX062673P IJX062674P IJX062683P IJX062698P IJX062701P IJX062706P IJX062716P IJX062727P IJX062734P IJX062736P IJX062738P IJX062739P IJX062741P IJX062747P IJX062763P IJX062764P
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    International Distribution Only: Australia and Canada.
  • Product Description
    Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic wireless communication between the heart device and the monitor takes place at times scheduled by the doctor or clinic. The gathered heart device information is sent over a telephone line to the clinic using a toll-free number. The monitor can also send wireless heart device alerts to the clinic automatically.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Managment
  • Manufacturer Address
    Medtronic Inc. Cardiac Rhythm Disease Managment, 8200 Coral Sea St. N.E., Saint Paul MN 55112
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA