Recall Z-3152-2024 ยท NVZ Pulse Generator, Permanent, Implantable
Medtronic Inc.
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 CR
| Date | Sep 13, 2024 (initiated Jul 11, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | Medtronic 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 t |
| Quantity | 18788 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.