BEUDAMED
    FDA Recall Open, Classified

    Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440

    Recall: Z-1582-2022 · Initiated August 9, 2022

    Recall

    Recall Number
    Z-1582-2022
    Event Number
    90735
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    DQY
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 9, 2022
    Posted
    August 25, 2022
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440

    Reason

    The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

    Action

    Stryker notified its consignees by issuing an URGENT: MEDICAL DEVICE VOLUNTARY Recall notice on 8/9/2022 by courier. The notice described the problem and the hazard, and requested the consignee take the following actions: "Required Actions 1. Immediately check your internal inventory for affected devices. 2. Segregate the affected units in a secure location for return to Stryker. 3. Circulate this Recall-Removal notice internally to all interested/affected parties. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform Stryker if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that Stryker can inform the recipients appropriately. 6. Please inform Stryker of any adverse events concerning the use of the subject devices. 7. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. 8. Return the completed form to your local Stryker Contact. 9. Product Return Information will be provided to you by your designated Sales Representative." UPDATE: On/about 2/13/2023, the amended letter was issued. It identified the lot number (which was in addition to the lot number in the initial recall) and provided the same instructions as were contained in the original notice issued 8/9/2022.

    Distribution

    International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea. UPDATE: The devices were also distributed to Russia. There was no U.S. distribution.

    Quantity

    184 devices (UPDATED)