BEUDAMED
    FDA Enforcement Class I Completed

    Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.

    Recall: Z-2577-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2577-2021
    Event ID
    88611
    Classification
    Class I
    Status
    Completed
    Product Type
    Devices
    Firm
    IMPERATIVE CARE INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 6, 2021
    Initiation Date
    August 13, 2021
    Classification Date
    September 29, 2021
    Address
    1359 Dell Ave, N/A, Campbell, CA, 95008-6609, United States

    Description

    Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.

    Reason

    There is a potential for distal end of catheters to fracture and become detached.

    Code Info

    Affected Lots: V2014902, F2026201, F2026802, F2028801, F2028901, F2029501, F2029701, F2030801, F2031101, F2035301, F2032502, F2100802, F2101301, F2104102, F2108101, F2108801, F2109601, F2109701, F2111101, F2110601, F2112301, F2113004, F2112001

    Distribution

    US nationwide distribution.

    Quantity

    3118 units