Events

Recall of Hancock Apical Left Ventricular Connector (LV Connector)

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
    69089
  • Event Risk Class
    Class 2
  • Event Number
    Z-2623-2014
  • Event Initiated Date
    2014-08-15
  • Event Date Posted
    2014-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129611
  • 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
    replacement Heart-valve - Product Code DYE
  • Reason
    Medtronic has decided to discontinue production and distribution of this low-volume product.
  • Action
    An Urgent Medical Device Recall letter, dated August, 2014, was sent to customers on 8/15/14 for specific serial numbers of Hancock Apical Left Ventricle Connector, model H174Axx, devices. This recall is the result of a decision by Medtronic to discontinue sales of this low volume product, in lieu of fulfilling new regulatory requirements to maintain its distribution in the United States. Customers are instructed to quarantine and return all listed product in their inventory to Medtronic and contact customer service at (800) 854-3570. Customers are instructed to complete the attached customer confirmation certificate and e-mail it to RS.CFQFCA@Medtronic.com or fax to Medtronic at (651) 367-0612 to the attention of Customer Focused Quality.

Device

Hancock Apical Left Ventricular Connector (LV Connector)
  • Model / Serial
    Serial Numbers: B146341, B146350
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of MD and TX.
  • Product Description
    Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. || Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension.
  • 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