BEUDAMED
    FDA Enforcement Class II Ongoing

    CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA1815SB/CNB, CORCA1820SB/CNB, CORCA2015SB/CNB, CORCA2020SB/CNB

    Recall: Z-0138-2023 · Reported November 2, 2022

    Enforcement

    Recall Number
    Z-0138-2023
    Event ID
    90804
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 2, 2022
    Initiation Date
    August 3, 2022
    Classification Date
    October 27, 2022
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    Description

    CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA1815SB/CNB, CORCA1820SB/CNB, CORCA2015SB/CNB, CORCA2020SB/CNB

    Reason

    Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury.

    Code Info

    Catalog Code-Lot (OUS Distribution Only): CORA1410/B- I2206909, I2318475, I2291980, I2286704; CORA1410S/B- I2206888; CORA1415/B- I2213361; CORA1615S/B- I2114518, H1517631, H1715532, H1756745, H1767115, H1771762, H1776067, H1784861, H1800979, H1808121, H1825693, I1781878, I1818817, I1837234, I1843704, I1855418, I1866359, I1952354, I1958525, I1971876, I1990075, I1998862, I2043630, I2070249, I2075810; CORA2010S/B- I2010414; CORCA1410S/B- I2259093; CORCA1410S/CNB- I2305358; CORCA1415S/B- I2210950; CORCA1610/CNB- I2291983; CORCA1615S/CNB- I2330683; CORCA1810SB/CNB- I2305359; CORCA1815SB/CNB- I2170254, I2205164; CORCA1820SB/CNB- I2325912; CORCA2015SB/CNB- I2318903, I2325926; CORCA2020SB/CNB- I2320880

    Distribution

    Worldwide distribution - US National distribution including in the states of FL, IL, OH, PA, CA, WI, VA, AZ, AR, MS, TN, MO, MA, MI, NY, NE, TX, WA, MN, LA, DE, IN, AL, NJ, OR, MD, GA, CT, OK, UT, KS, NC, CO, KY, WV, AK, NV, RI, SC, ND, NH, MT and the countries of Finland, Denmark, United Arab Emirates, Spain, Sweden, Norway, Jordan, Australia, Germany, Austria, Italy, United Kingdom, France, Canada, Mexico, Puerto Rico, Chile, Reunion, Belgium, Switzerland, Japan, South Africa, Qatar, Russian Federation, Hungary, Thailand, Namibia, Colombia, New Zealand, Netherlands, Saudi Arabia, Costa Rica, Oman, Cyprus, Slovenia, Croatia, China.

    Quantity

    2894