BEUDAMED
    FDA Recall Open, Classified

    Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Component: N/A

    Recall: Z-0574-2026 · Initiated October 8, 2025

    Recall

    Recall Number
    Z-0574-2026
    Event Number
    97803
    Firm
    Sterilmed, Inc.
    FEI Number
    3011276773
    Product Code
    OWQ
    Status
    Open, Classified
    Root Cause
    Reprocessing Controls
    Initiated
    October 8, 2025
    Posted
    November 20, 2025
    Address
    5010 Cheshire Pkwy N, Ste 2, Plymouth, MN, 55446-4101

    Description

    Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Component: N/A

    Reason

    Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.

    Action

    Initial phone call notification was performed 10/10/2025 to affected customers. Customers were instructed to immediately stop use of identified devices. Affected products should be segregated. Follow-up written notification was sent to customers on 10/17/25 which included instructions on how to return affected products.

    Distribution

    United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah

    Quantity

    4