BEUDAMED
    FDA Recall Open, Classified

    Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US

    Recall: Z-0557-2022 · Initiated December 17, 2021

    Recall

    Recall Number
    Z-0557-2022
    Event Number
    89418
    Firm
    Covidien Llc
    FEI Number
    1282497
    Product Code
    LIT
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 17, 2021
    Posted
    February 3, 2022
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

    Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US

    Reason

    The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy.

    Action

    On December 17, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Patient recommendation: Continue to monitor patients according to your hospital's patient management process. Required Actions: 1. Please immediately quarantine and discontinue use of the affected item code. 2. Please return affected product as indicated below. All products from the affected item code and lots listed below must be returned. 3. If you have distributed the products listed above, please promptly forward the information from this letter to those recipients. 4. Please complete the Recalled Product Return Form even if you do not have inventory. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Germany, Israel, Italy, Portugal, Spain, Chile, Singapore, and China.

    Quantity

    1,994 devices