BEUDAMED
    FDA Recall Open, Classified

    Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Catalog / Model Numbers: IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001

    Recall: Z-1110-2022 · Initiated March 30, 2022

    Recall

    Recall Number
    Z-1110-2022
    Event Number
    89967
    Firm
    Medtronic Inc
    FEI Number
    3001504994
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    March 30, 2022
    Address
    710 Medtronic Pkwy, Mailstop Ls245, Minneapolis, MN, 55432-5603

    Description

    Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Catalog / Model Numbers: IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001

    Reason

    Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.

    Action

    Starting 30-Mar-2022, Medtronic issued an Urgent Medical Device Notice by letter to VAD Coordinators at customer sites in order to inform them of the errors and the corrections impacting the Instructions for Use, Patient Manual, and Emergency Responder Guide for the HVAD System. In addition to the Urgent Medical Device Notice a patient template was provided to facilitate the VAD Coordinators in notifying their patients of the issues to the Patient Manual. Customer Instructions: "Please ensure your patients on support are aware of the changes to the PM. "Please share this notice with everyone in your organization who needs to be aware. "Continue to monitor patients per your practice's standard follow-up procedures. "Please complete the enclosed Customer Confirmation Form and email to [email protected]. For questions regarding this material, customers should contact their Medtronic Field Representative, MCS Customer Service or (877) 367-4823. .

    Distribution

    Worldwide Distribution: US (nationwide) and OUS to countries of: Australia, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, INDIA, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom

    Quantity

    21,118 pieces of product literature