BEUDAMED
    FDA Recall Open, Classified

    Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU

    Recall: Z-0946-2021 · Initiated November 19, 2020

    Recall

    Recall Number
    Z-0946-2021
    Event Number
    86924
    Firm
    Heartware, Inc.
    FEI Number
    3007042319
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 19, 2020
    Posted
    February 4, 2021
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807

    Description

    Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU

    Reason

    Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than pump in the overall population.

    Action

    On 11/19/2020, notifications initiated to inform about recall. Additional notifications sent on 5/18/2022 (https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-urgent-medical-device-notice-update-june-2022.pdf), 10/13/2022 and May 08, 2024. On 8/20/2025, communications initiated to inform about algorithm C controller that will attempt to pump restart using algorithm A, and if needed algorithm B. It will mitigate controller resetting. Blue line highlights on algorithm C controller exterior differentiates it from previous versions. Healthcare providers asked to speak with patients. Issue does not cause a running pump to stop; rather, a failure to restart may follow a pump stop event. A controller AC adapter should be attached to any controller being used to restart a stopped pump, which will provide consistent power for restart attempts. If unavailable, connect two fully or partially charged batteries to the controller as soon as possible during any pump restart attempt. Reinforce patient manual and instructions for use: -Do NOT disconnect the driveline from controller. - ALWAYS ensure two power sources are connected to controller. - NEVER disconnect both power sources (batteries and AC or DC adapter) from controller at the same time; one external power source should remain connected to controller at all times. - Do NOT exchange controller unless explicitly directed by a high priority alarm condition or a VAD team member. - Reinforce the proper response to a Controller Fault alarm and Electrical Fault alarm. These are medium priority alarms unrelated to an immediate pump stop. These alarms will result in the word Call in the controller display, notifying the patient to call their clinician. - Reinforce making good connections of power sources and the data cable in the controller ports. Complete and return response form via email to [email protected]

    Distribution

    Worldwide - US Nationwide

    Quantity

    19,562 units