Events

Recall of Device Recall Model 7305 Mosaic Aortic Obturator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Cardiovascular Surgery-the Heart Valve Division.

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
    67242
  • Event Risk Class
    Class 2
  • Event Number
    Z-0908-2014
  • Event Initiated Date
    2014-01-09
  • Event Date Posted
    2014-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125069
  • 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
    heart-valve, non-allograft tissue - Product Code LWR
  • Reason
    Medtronic, inc. initiated a recall of medtronic mosaic aortic obturator model 7305 used with the mosaic porcine aortic bioprosthesis, model number 305, because of higher-than-expected transvalvular gradients occurring post implant.
  • Action
    Medtronic sent an Customer Notification letter dated January 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Medtronic recommends surgeons continue to remain diligent in selecting the appropriate size of Mosaic Aortic Bioprosthesis. Adoption of the updated Mosaic Aortic Bioprosthesis sizing chart (iEOA chart) and Mosaic Obturators/Sizers will facilitate optimal aortic valve size selection. Your Medtronic Field Representative will be contacting you about receiving a new Mosaic Aortic Obturator/Sizer set and sizing chart. If you would prefer to order the new Mosaic Aortic Obturator/Sizer set directly through Medtronic Customer Service, contact them at 1-800-848-9300. Medtronic will notify all applicable regulatory agencies, as required, about this matter. Please share this notification with others in your organization as appropriate. We appreciate your review of this notification and apologize for the inconvenience that it may cause. If you have any questions, please contact your Medtronic Field Representative or Lifeline Technical Services at 1-877-526-7890.

Device

Device Recall Model 7305 Mosaic Aortic Obturator
  • Model / Serial
    Model 7305.  Lot/Serial Numbers:  The catalog numbers for the Obturator/Sizer are 7305C, 7305UX, and 7305OD.  Scope of this notification includes all Mosaic Obturators/Sizers, used with Mosaic Porcine Aortic Bioprosthesis implants.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Product Description
    Product Name: Model 7305- Mosaic Aortic Obturator || The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
  • Manufacturer
    Medtronic Cardiovascular Surgery-the Heart Valve Division

Manufacturer

Medtronic Cardiovascular Surgery-the Heart Valve Division
  • Manufacturer Address
    Medtronic Cardiovascular Surgery-the Heart Valve Division, 1851 E Deere Ave, Santa Ana CA 92705-5720
  • 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