Class II Recall

2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORT

Summary

The FDA issued a Class II for 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product by Medtronic Inc.. Reason: Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen .

Details

Source

Device Recall

External ID

Z-3152-2024

Action Date

2024-09-25

Status

Ongoing

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

Lot/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

Quantity Affected: 18788 units

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

Worldwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-07-11

Company

Medtronic Inc.

Mounds View, MN

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Medtronic Inc. has 83 FDA actions in our database, including 46 recalls and 37 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Medtronic Inc. have FDA actions?

Medtronic Inc. has 83 FDA actions in our database, including 46 recalls and 37 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-3152-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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