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

FDA device recall Z-3152-2024 · posted 2024-09-13 · Open, Classified

Recall details

Recalling firm

Medtronic Inc.

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.

Action taken

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 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."

Root cause

Device Design

Status

Open, Classified

Product code

NVZ

Quantity affected

18788 units

Distribution

Worldwide distribution.

Date initiated

2024-07-11

Date posted

2024-09-13

Location

Mounds View, MN