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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

Medtronic Inc.: Medtronic CareLink 2090 Programmers Recalled for Autonomous Cursor Motion

Agency Publication Date: September 13, 2024
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Summary

Medtronic is recalling approximately 18,788 CareLink 2090 Programmers with serial number prefixes PKK0 and PKK1 because they may exhibit unintended cursor movement. This issue occurs when Finger Touchscreen capability is enabled by software version 3.2 or higher, potentially causing the programmer to act as if a user is touching the screen when they are not. These devices are used worldwide for managing cardiac rhythm devices, and Medtronic is initiating this voluntary recall to address the software interaction and hardware compatibility issue.

Risk

Unintended or autonomous cursor movement on the programmer's screen could lead to incorrect settings being selected or accidental programming changes to a patient's medical device. This malfunction creates a risk of improper therapy delivery or diagnostic errors during patient follow-up sessions.

What You Should Do

  1. Identify your device by checking the serial number prefix; only Medtronic CareLink 2090 programmers starting with serial number prefixes PKK0 or PKK1 are affected by this recall.
  2. Verify the software version currently installed on your 2090 programmer; the issue is specifically triggered when Finger Touchscreen capability is enabled on software version 3.2 or higher.
  3. If you own an affected device, contact Medtronic Inc. or your local Medtronic representative to receive specific instructions on software updates or hardware adjustments to resolve the touchscreen issue.
  4. Consult with your healthcare facility's biomedical engineering or clinical technology department to ensure all affected programmers in your inventory are accounted for and updated.
  5. For additional information or assistance regarding this recall, contact Medtronic Inc. at their Mounds View, Minnesota facility or call the FDA's medical device information line at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Software update or configuration change

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: 2090 Programmers Portable CRM
Model / REF:
2090
UPC Codes (109):
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
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 209031 Programmers Portable CRM
Model / REF:
209031
UPC Codes:
00721902171222
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090AA Programmers Portable CRM
Model / REF:
2090AA
UPC Codes:
00721902171079
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090AA4 Programmers Portable CRM
Model / REF:
2090AA4
UPC Codes:
00721902824692
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090AC Programmer-Portable CRM Software
Model / REF:
2090AC
UPC Codes:
00721902059100
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090AM Programmer CareLink Hong Kong Asia
Model / REF:
2090AM
UPC Codes:
00721902171154
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090CHEN Programmer Pkg-Assy
Model / REF:
2090CHEN
UPC Codes:
00721902246357
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090CHFR Programmer Pkg-Assy
Model / REF:
2090CHFR
UPC Codes:
00721902246364
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090CL Programmer Intl-Japan Mkt
Model / REF:
2090CL
UPC Codes:
00721902480201
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090EN Programmer Pkg-Assy UK
Model / REF:
2090EN
UPC Codes:
00721902246159
00721902246173
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090FR Programmer Pkg-Assy IN
Model / REF:
2090FR
UPC Codes:
00721902246203
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090LDEN Programmer-Portable Loane
Model / REF:
2090LDEN
UPC Codes:
00721902841903
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090NL Programmer Pkg-Assy IN
Model / REF:
2090NL
UPC Codes:
00721902246272
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090W Programmer Telemetry C
Model / REF:
2090W
UPC Codes:
00613994127631
00613994435354
00613994581549
00885074301440
00885074310596
00885074310633
00885074310657
00885074310930
00885074312866
00885074312873
00885074313047
00885074313108
00885074313115
00885074313139
00885074313146
00885074313153
00885074313160
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090WCHDE Programmer Swiss-German
Model / REF:
2090WCHDE
UPC Codes:
00885074313191
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090WCHEN Programmer Swiss-English
Model / REF:
2090WCHEN
UPC Codes:
00885074313177
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090WCHFR Programmer Swiss-French
Model / REF:
2090WCHFR
UPC Codes:
00885074313184
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090WDE Programmer German Mkt
Model / REF:
2090WDE
UPC Codes:
00885074314921
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090WFR Programmer French Mkt
Model / REF:
2090WFR
UPC Codes:
00885074313009
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090WLD Prog All Languages W/Analyzer
Model / REF:
2090WLD
UPC Codes:
00885074357416
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1
Product: 2090WNL Programmer Netherlands Mkt
Model / REF:
2090WNL
UPC Codes:
00885074313122
Lot Numbers:
Serial Number Prefix: PKK0
Serial Number Prefix: PKK1

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95176
Status: Active
Manufacturer: Medtronic Inc.
Sold By: Medtronic Inc.; Authorized Medical Distributors
Manufactured In: United States
Units Affected: 18788 units
Distributed To: Nationwide

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.