BEUDAMED
    FDA Recall Open, Classified

    Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)

    Recall: Z-1590-2023 · Initiated April 17, 2023

    Recall

    Recall Number
    Z-1590-2023
    Event Number
    91955
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    OZD
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 17, 2023
    Posted
    May 18, 2023
    Address
    22 Cherry Hill Dr, Danvers, MA, 01923-2575

    Description

    Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)

    Reason

    The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.

    Action

    An URGENT MEDICAL DEVICE RECALL (REMOVAL) notification letter dated 4/17/23 was sent to customers. ACTIONS RELATED TO THIS RECALL (REMOVAL) Abiomed will replace all affected pumps that are still in your inventory using a phased replacement approach. The benefits of using the pump outweigh the risks of pump stop due to purge leaks. To mitigate leaks from sidearm damage and/or the yellow luer, it is critical to refer to the Important Information section below for best practices in the event you must use an affected Impella 5.5 with SmartAssist Set while you wait for a replacement pump. Please contact your Abiomed representative to receive a Sidearm Retainer and/or a Codan Extension Tubing Set if you do not have one. See Attachment 1 to this letter for your specific replacement date. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal). Refer to Attachment 1 for the Product Identification Tool to identify products that are subject to this Recall (Removal) by using package labels. DO NOT USE THE SUBJECT PRODUCTS UNLESS NO OTHER PRODUCT IS AVAILABLE. 2. Contact the Abiomed customer support center to coordinate the return of the subject products according to your scheduled date in Attachment 1. 3. Review the IMPORTANT INFORMATION section above for best practices in the event you must use these devices while you wait for a replacement. 4. Review, complete all fields, sign, and return the attached Business Response Form (BRF) on the last page of this letter to the Recall Coordinator identified in this document. IMPORTANT: Please complete the attached Business Response Form even if you have used any units of the subject product on hand. 5. Forward this notice to any personnel in your facility who need to be informed. 6. If any of the product subject to this recall (removal) has been forwarded to another facility, contact that facility and provide a copy of this notice to the releva

    Distribution

    US Nationwide. Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland, Austria, France, Great Britain, Croatia, Serbia, Norway, Slovenia, Germany

    Quantity

    610 units