Z-3152-2024 Class II Ongoing

Recalled by Medtronic Inc. — Mounds View, MN

Recall Details

Product Type
Devices
Report Date
September 25, 2024
Initiation Date
July 11, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
18788 units

Product 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 for Recall

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.

Distribution Pattern

Worldwide distribution.

Code Information

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