Medtronic CareLink 2090 Programmer Recall: Autonomous Cursor Motion
Medtronic is recalling CareLink 2090 Programmers (serial number prefixes PKK0 and PKK1) worldwide due to potential autonomous cursor motion when Finger Touchscreen capability is enabled with software version 3.2 or higher. Approximately 18,788 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a cardiac programmer with potential for unintended operation due to autonomous cursor motion. The source explicitly states no illnesses or injuries have been reported, and the hazard is characterized as potential rather than confirmed. Per the severity rubric, a risk-of-harm product without reported injury scores as High (3).
Plain-English summary
Medtronic Inc. is recalling Medtronic CareLink 2090 Programmers with serial number prefixes PKK0 and PKK1. These are portable programmers used to configure and monitor implantable cardiac devices. The recall was issued because the programmers have the potential for autonomous cursor motion (unintended cursor movement) when the Finger Touchscreen capability is enabled with software version 3.2 or higher.
This Class II recall affects approximately 18,788 units distributed worldwide. The affected devices include multiple regional variants marketed in various countries.
Autonomous cursor motion could potentially result in unintended changes to device programming parameters or settings. No illnesses or injuries have been reported. Affected healthcare facilities and clinicians should contact Medtronic for guidance on software updates, device replacement, or alternative solutions.
The recalled product
- Product
- 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…
- Manufacturer
- Medtronic Inc.
- Affected units
- 18,788
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 00613994136497
- 00613994136503
- 00613994136510
- 00613994136527
- 00613994136534
- 00613994136565
- 00613994136596
- 00613994136619
- 00613994136626
- 00613994175076
- 00613994175083
- 00613994175090
- 00613994175106
- 00613994175120
- 00613994175137
- 00613994175144
- 00613994175151
- 00613994175168
- 00613994175175
- 00613994175182
Distribution
Distribution scope not specified by the agency.
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