BEUDAMED
    FDA Recall Open, Classified

    HeartWare Ventricular Assist Device (HVAD) System

    Recall: Z-0726-2022 · Initiated January 27, 2022

    Recall

    Recall Number
    Z-0726-2022
    Event Number
    89559
    Firm
    Heartware, Inc.
    FEI Number
    3007042319
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    January 27, 2022
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807

    Description

    HeartWare Ventricular Assist Device (HVAD) System

    Reason

    Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.

    Action

    Starting 27-Jan-2022 and ending 02-FEB-2022, Medtronic initiated an Urgent Medical Device Notice to global customers to inform them of the intent to update the cleaning instructions for power source connector pins on the HVAD" System Monitor AC Adapter, DC Adapter, and Batteries. The communication provided customers the updated instructions, the complaints received as well as the potential hazards of cleaning the power source connector pins. In addition to the Urgent Medical Device Notice a patient template was provided to facilitate the VAD Coordinators in notifying their patients. In the United States the notice was delivered to VAD Coordinators via UPS 2-day delivery. Consignees will be asked to confirm receipt of the letter and that they have acknowledge the actions taken for those nonimplanted, affected product. In addition, a courtesy copy was sent to shared care clinics for those affected patients. Outside the United States the notice will be delivered to consignees through a locally approved method. Consignees will be asked to confirm receipt of the letter and that they have taken the recommended action. Confirmation of the communication will be received by locally approved methods.

    Distribution

    Distribution throughout the United States. OUS distribution in Argentina, Armenia, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea (South), Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritius, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.

    Quantity

    197,889 units