BEUDAMED
    FDA Recall Open, Classified

    SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

    Recall: Z-1022-2023 · Initiated November 2, 2022

    Recall

    Recall Number
    Z-1022-2023
    Event Number
    91330
    Firm
    SynCardia Systems LLC
    FEI Number
    3003761017
    Product Code
    LOZ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    November 2, 2022
    Posted
    January 27, 2023
    Address
    1992 E Silverlake Rd, Tucson, AZ, 85713-3865

    Description

    SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

    Reason

    Due to tears reported tears in the cannula due to wear and tear stress.

    Action

    On 11/02/2022, the firm send an "Urgent Medical Device Correction" Letter via email alerting customers that there is the potential for hole or tear that may occur in the pneumatic cannulae of the temporary Total Artificial Heart (TAH-t). Customers are instructed to: Prior to a hole/tear occurring, train patients to properly inspect the cannulae for holes/ tears and to recognize the signs of a tear/hole. If a hole/tear occurs, the patient should immediately call the hospital to arrange for repair. For Clinicians Only: While SynCardia has not validated the below instructions, there have been literature articles[i][ii] on this method to repair a cannula tear by removing the damaged cannula segment. The repair requires a backup Companion 2 or Freedom portable driver, a secondary driver driveline connector, zip ties, and high-leverage cable cutters. The repair should be implemented quickly by at least two operators following the instructions below. One operator will prepare and operate the backup driver. A second operator will cut and reconnect the cannula. 1. Inspect cannulae for any sign of a tear, hole, or cut, which can be visually detected or detected by listening for a hissing sound or whooshing of air. 2. Prepare a backup driver with an appropriate secondary connector attached to the affected driver driveline. Power on the selected backup driver and keep it on standby for the next repair steps. 3. Using a high-leverage cable cutter cut the cannula through the coil wire slightly distal to the tear to minimize the loss of cannula length. Insert a secondary connector barb (connected to the powered backup driver) into the cut cannula. Secure the cannula to the new connector with zip ties. 4. Disconnect the other undamaged cannula from the primary driver and reconnect it to the backup driver. 5. Change backup driver from standby to run with the correct settings for the patient. For questions contact Customer Support Manager at 1-866-480-1122. In addition to custome

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, IA. IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI. The countries of Australia, Austria, Canada, Croatia, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lebanon, Lithuania, Macedonia, Poland, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

    Quantity

    1,732 systems