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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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 Class 2 Device Recall Medtronicsee related information
Date Initiated by FirmJuly 11, 2024
Date PostedSeptember 13, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3152-2024
Recall Event ID 95176
PMA NumberP890003S401 
Product Classification Pulse generator, permanent, implantable - Product Code NVZ
Product2090 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
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
Recalling Firm/
Manufacturer		 Medtronic Inc.
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information ContactTechnical Services
763-638-1991
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionMedtronic issued a MEDICAL DEVICE CORRECTION notice to its consignees on 07/11/2024 via email or UPS 2-day delivery. The notice explained the issue, potential risk, and provided the following: "Instrument Management Recommendations Software updates are necessary to maintain proper programmer function. Medtronic representatives will assist in performing the software update on all Medtronic CareLink 2090 programmers and assess proper function. Medtronic representatives will assist with returning programmers needing repair or replacement. " Following review of this letter, please complete the enclosed Confirmation Form and email it to RS.FCACRM@medtronic.com to confirm receipt of this notification. " Please forward this notice to others who need to be aware within your organization."
Quantity in Commerce18788 units
DistributionWorldwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = NVZ
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