BEUDAMED
    FDA Recall Open, Classified

    Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

    Recall: Z-2128-2023 · Initiated May 26, 2023

    Recall

    Recall Number
    Z-2128-2023
    Event Number
    92521
    Firm
    Abiomed, Inc.
    FEI Number
    1220648
    Product Code
    DYB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 26, 2023
    Posted
    July 11, 2023
    Address
    24 Cherry Hill Dr, Danvers, MA, 01923-2575

    Description

    Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

    Reason

    There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.

    Action

    An URGENT: VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) notification letter was delivered to customers on 5/23/23. Customers were also contacted via telephone on 5/26/23. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal). DO NOT USE THE SUBJECT PRODUCTS. 2. Contact your Abiomed local clinical field staff to coordinate the return of the subject products. 3. 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. 4. Forward this notice to any personnel in your facility who needs to be informed. 5. If any of the product subject to this recall (removal) has been forwarded to another facility, contact that facility immediately and provide a copy of this notice to the relevant personnel. 6. Post a copy of this field safety notice in a visible area for awareness. 7. As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA s MedWatch Adverse Event Reporting Program using the link below: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reportingprogram/reporting-serious-problems-fda If you have questions or concerns regarding this notice, please contact (Shashi Thoutam) directly at +1(734) 262-6255 and/or your local clinical field staff.

    Distribution

    US Nationwide distribution in the states of MN, NJ, TN.

    Quantity

    37 units