BEUDAMED
    FDA Enforcement Class II Ongoing

    2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description: SFTWR 2090AC PROGRAMMER-PORTABLE CRM W/; f) 2090AM, Product Description: PROGRAMMER CARELINK HONG KONG ASIA; g) 2090CHEN, Product Description: PRGM 2090CHEN PKG-ASSY PROGRAMMER 2090; h) 2090CHFR, Product Description: PRGM 2090CHFR PKG-ASSY PROGRAMMER 2090; i) 2090CL, Product Description: PROGRAMMER 2090CL INTL-JAPAN MKT; j) 2090EN, Product Description: PRGM 2090EN PKG-ASSY PROGRAMMER 2090 UK; k) 2090FR, Product Description: PRGM 2090FR PKG-ASSY PROGRAMMER 2090 IN; l) 2090LDEN, Product Description: PRGM 2090LDEN PROGRAMMER-PORTABLE LOANE; m) 2090NL, Product Description: PRGM 2090NL PKG-ASSY PROGRAMMER 2090 IN; n) 2090W, Product Description: PROGRAMMER 2090W TELEMETRY C; o) 2090WCHDE, Product Description: PROGRAMMER 2090WCHDE SWISS-GERMAN; p) 2090WCHEN, Product Description: PROGRAMMER 2090WCHEN SWISS-ENGLISH; q) 2090WCHFR, Product Description: PROGRAMMER 2090WCHFR SWISS-FRENCH; r) 2090WDE, Product Description: PROGRAMMER 2090WDE GERMAN MKT; s) 2090WFR, Product Description: PROGRAMMER 2090WFR FRENCH MKT; t) 2090WLD, Product Description: PROG 2090WLD ALL LANGUAGES W/ANALYZER; u) 2090WNL, Product Description: PROGRAMMER 2090WNL NETHERLANDS MKT

    Recall: Z-3152-2024 · Reported September 25, 2024

    Enforcement

    Recall Number
    Z-3152-2024
    Event ID
    95176
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 25, 2024
    Initiation Date
    July 11, 2024
    Classification Date
    September 13, 2024
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391, United States

    Description

    2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description: SFTWR 2090AC PROGRAMMER-PORTABLE CRM W/; f) 2090AM, Product Description: PROGRAMMER CARELINK HONG KONG ASIA; g) 2090CHEN, Product Description: PRGM 2090CHEN PKG-ASSY PROGRAMMER 2090; h) 2090CHFR, Product Description: PRGM 2090CHFR PKG-ASSY PROGRAMMER 2090; i) 2090CL, Product Description: PROGRAMMER 2090CL INTL-JAPAN MKT; j) 2090EN, Product Description: PRGM 2090EN PKG-ASSY PROGRAMMER 2090 UK; k) 2090FR, Product Description: PRGM 2090FR PKG-ASSY PROGRAMMER 2090 IN; l) 2090LDEN, Product Description: PRGM 2090LDEN PROGRAMMER-PORTABLE LOANE; m) 2090NL, Product Description: PRGM 2090NL PKG-ASSY PROGRAMMER 2090 IN; n) 2090W, Product Description: PROGRAMMER 2090W TELEMETRY C; o) 2090WCHDE, Product Description: PROGRAMMER 2090WCHDE SWISS-GERMAN; p) 2090WCHEN, Product Description: PROGRAMMER 2090WCHEN SWISS-ENGLISH; q) 2090WCHFR, Product Description: PROGRAMMER 2090WCHFR SWISS-FRENCH; r) 2090WDE, Product Description: PROGRAMMER 2090WDE GERMAN MKT; s) 2090WFR, Product Description: PROGRAMMER 2090WFR FRENCH MKT; t) 2090WLD, Product Description: PROG 2090WLD ALL LANGUAGES W/ANALYZER; u) 2090WNL, Product Description: PROGRAMMER 2090WNL NETHERLANDS MKT

    Reason

    Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.

    Code Info

    2090 Programmers with serial number prefixes PKK0 and PKK1: a) GTIN: 00613994136480, 00613994136497, 00613994136503, 00613994136510, 00613994136527, 00613994136534, 00613994136565, 00613994136596, 00613994136619, 00613994136626, 00613994175076, 00613994175083, 00613994175090, 00613994175106, 00613994175120, 00613994175137, 00613994175144, 00613994175151, 00613994175168, 00613994175175, 00613994175182, 00613994175205, 00613994175212, 00613994175229, 00613994175236, 00613994175243, 00613994175250, 00613994175267, 00613994175281, 00613994175298, 00613994175304, 00613994175311, 00613994175328, 00613994175335, 00613994175342, 00613994175366, 00613994175373, 00613994175380, 00613994175397, 00613994175403, 00613994175410, 00613994175434, 00613994175465, 00613994175489, 00613994175540, 00613994175588, 00613994175595, 00613994203182, 00613994360922, 00613994434883, 00613994434890, 00613994434944, 00613994435002, 00613994435255, 00613994435316, 00613994580863, 00613994580894, 00613994580931, 00613994580962, 00613994581013, 00613994581051, 00613994581075, 00613994581105, 00613994581150, 00613994581167, 00613994581174, 00613994581181, 00613994581204, 00613994581211, 00613994581228, 00613994581235, 00613994581242, 00613994581549, 00613994581570, 00613994581587, 00613994581594, 00613994581624, 00643169440128, 00643169440166, 00643169440173, 00643169440197, 00643169440203, 00643169440937, 00643169537750, 00643169537774, 00643169537811, 00643169537828, 00643169537835, 00643169537842, 00643169537859, 00643169537866, 00643169537880, 00643169537910, 00643169537927, 00643169538016, 00643169629004, 00643169629011, 00643169629028, 00643169629035, 00643169629042, 00643169629066, 00721902246227, 00721902246234, 00721902246241, 00721902246265, 00721902246289, 00721902246302, 00721902246326, 00721902246333; b) GTIN: 00721902171222; c) GTIN: 00721902171079; d) GTIN: 00721902824692; e) GTIN: 00721902059100; f) GTIN: 00721902171154; g) GTIN: 00721902246357; h) GTIN: 00721902246364; i) GTIN: 00721902480201; j) GTIN: 00721902246159, 00721902246173; k) GTIN: 00721902246203; l) GTIN: 00721902841903; m) GTIN: 00721902246272; n) GTIN: 00613994127631, 00613994435354, 00613994581549, 00885074301440, 00885074310596, 00885074310633, 00885074310657, 00885074310930, 00885074312866, 00885074312873, 00885074313047, 00885074313108, 00885074313115, 00885074313139, 00885074313146, 00885074313153, 00885074313160; o) GTIN: 00885074313191; p) GTIN: 00885074313177; q) GTIN: 00885074313184; r) GTIN: 00885074314921; s) GTIN: 00885074313009; t) GTIN: 00885074357416; u) GTIN: 00885074313122

    Distribution

    Worldwide distribution.

    Quantity

    18788 units