Events

Recall of Amplia MRI Quad CRT0 SureScanClaria MRI Quad CRTD SureScanCompia MRI Quad CRTD SureScan

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

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
    76853
  • Event Risk Class
    Class 2
  • Event Number
    Z-2117-2017
  • Event Initiated Date
    2017-04-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154406
  • 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
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
  • Reason
    An unexpected transient mode switch behavior was detected by medtronic during systems testing that affects amplia' "', claria'"', and compia'"' quad crt-d mri devices.
  • Action
    Medtronic sent an Important Medical Device Information letter dated March 2017. The letter is addressed to Physician or Healthcare Professional. The letter describes the issue and the product involved in the recall. It informs consignees of the upcoming software update and provides directions in Appendix A on how to apply the update to patient devices and to verify that devices are operating correctly.. For questions, contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636. *Recall has not been initiated in USA only in Japan. UPDATE: Consignees were sent an "Update to Medical Device Correction" letter dated April 2017on 4/26/2017. The letter was addressed to Physicians or Healthcare Professional. The letter informed consignees that the programmer software update is approved for installation. For questions, or if we can be of further assistance, please contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636. Recall was initiated in USA on 4/26/2017.

Device

Amplia MRI Quad CRT0 SureScanClaria MRI Quad CRTD SureScanCompia MRI Quad CRTD SureScan
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    USA: Nationwide including DC & PR. Worldwide- Distribution : Australia Egypt Ireland Morocco Austria Finland Israel Netherlands Bangladesh France Italy New Zealand Belgium Germany Japan Norway Brunei Darussalam Greece Jordan Oman Canada Guadeloupe Kuwait Poland Cayman Islands Hong Kong Lebanon Portugal Cyprus Hungary Luxembourg Denmark India Macedonia Reunion Dominican Republic Iran Malaysia Singapore
  • Product Description
    Amplia MRI Quad CRT-0 SureScan || Claria MRI Quad CRT-D SureScan || Compia MRI Quad CRT-D SureScan
  • Manufacturer
    Medtronic Inc., Cardiac Rhythm and Heart Failure

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure
  • Manufacturer Address
    Medtronic Inc., Cardiac Rhythm and Heart Failure, 8200 Coral Sea St NE, Mounds View MN 55112-4391
  • 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