Medtronic CareLink® Programmer 2090 (UDI 00613994175403)Recalls & reported problems

Medtronic, Inc. · PROG 2090 TEL C US EN SW JUN06 · Class 3

All models of Medtronic CareLink Programmer (8)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Medtronic CareLink 2090 programmer, used to check pacemakers, has 108 malfunction reports, with no deaths and 3 injuries. Some reports describe the touchscreen moving the cursor on its own or failing touch tests, and others describe screen, software, or printer failures. 3 recalls name this device: 2 are open, over possible cursor movement when touch features are turned on and over telemetry cybersecurity weaknesses, and 1 is closed, over an error in the battery life display.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 108
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 3

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00613994175403), received between Apr 6, 2017 and Apr 3, 2025 — classified as 3 injuries, 105 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (23 reports).

3 FDA recall records name this device's identifier, 2 still open.

10 other recalls cover devices cleared under the same FDA submission (P890003); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Jul 11, 2024Open, Classified
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.
Z-3152-2024 · Root cause: Device Design · Recall details · FDA record ↗
Jan 30, 2020Open, Classified
Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.
Z-1524-2020 · Root cause: Software design · Recall details · FDA record ↗
Jan 17, 2019Terminated
There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time (RRT).
Z-0795-2019 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Device problems

Display or Visual Feedback Problem23
Computer Operating System Problem22
Device Difficult to Program or Calibrate22
No Display/Image19
Computer Software Problem13
Overheating of Device12
Failure to Power Up7
Mechanical Problem7

Patient problems

No Clinical Signs, Symptoms or Conditions54
No Patient Involvement25
No Known Impact Or Consequence To Patient23
No Consequences Or Impact To Patient5
Dizziness1
Shock from Patient Lead(s)1

Recent adverse event reports

The 25 most recent of 108 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 3, 2025No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE PROGRAMMER'S TOP SECTION OF THE SCREEN WAS UNABLE TO RESPOND TO FINGER TOUCH OR STYLUS INPUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21767316 ↗
MalfunctionFeb 21, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER FAILED THE FINGER TOUCH TEST FOR CURSOR MISALIGNMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21431170 ↗
MalfunctionDec 13, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AUTONOMOUS CURSOR MOVEMENT AND THE TOUCHSCREEN ASSESSMENT HAD FAILED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20923637 ↗
MalfunctionNov 22, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER'S CURSOR RANDOMLY MOVED ABOUT ON THE SCREEN WITHOUT ANY INPUT FROM THE USER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20756165 ↗
MalfunctionNov 12, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER FAILED THE TOUCHSCREEN TEST AND THE CURSOR MOVED WITHOUT ANY MANUAL INPUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20664351 ↗
MalfunctionNov 12, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED AUTONOMOUS CURSOR MOVEMENT AFTER THE MOST RECENT SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20661815 ↗
MalfunctionNov 8, 2024Display or Visual Feedback Problem; Computer Operating System Problem; Display or Visual Feedback Problem; Computer Operating System Problem
IT WAS REPORTED THAT THE PROGRAMMER PRINTER WAS UNABLE TO WORK AND WAS UNABLE TO ADVANCE WHEN PAPER WAS PLACED IN THE PRINTER DRAWER. IT WAS NOTED THAT THE PROGRAMMER WAS VERY SLUGGISH. THE PROGRAMMER HAS BEEN RETURNED FOR EVALUATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20638945 ↗
MalfunctionNov 1, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE PROGRAMMER¿S TOUCH SCREEN WAS NOT ENABLED AFTER THE MOST RECENT SOFTWARE UPDATE. IT WAS NOTED THAT THE PROGRAMMER PERFORMED THE AUTONOMOUS CURSOR TEST AND IT WAS SUCCESSFUL. THE PROGRAMMER REMAINS IN USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20585795 ↗
MalfunctionOct 31, 2024Display or Visual Feedback Problem; Material Integrity Problem; Display or Visual Feedback Problem; Material Integrity Problem
IT WAS REPORTED THAT THE PROGRAMMER'S CURSOR MOVED AROUND THE SCREEN WITHOUT ANY USER INPUT. IT WAS NOTED THAT THE PROGRAMMER HAD FAILED THE TOUCHSCREEN TEST AFTER THE RECENT SOFTWARE UPDATE. IT WAS FURTHER NOTED THAT THE KEYBOARD HINGE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577558 ↗
MalfunctionOct 29, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER DEMONSTRATED AUTONOMOUS CURSOR MOVEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20558063 ↗
MalfunctionOct 8, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER FAILED THE AUTONOMOUS CURSOR TEST FOR AUTONOMOUS CURSOR MOVEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20395541 ↗
MalfunctionOct 4, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER FAILED THE AUTONOMOUS CURSOR TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20366818 ↗
MalfunctionSep 17, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER FAILED THE CURSOR TEST AFTER THE RECENT SOFTWARE UPDATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20235155 ↗
MalfunctionSep 17, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AUTONOMOUS CURSOR MOVEMENT AND FAILED TOUCHSCREEN ASSESSMENT AFTER THE RECENT SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20235064 ↗
MalfunctionSep 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER FAILED THE TOUCHSCREEN TEST FOR AUTONOMOUS CURSOR MOVEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20156347 ↗
MalfunctionSep 6, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER FAILED THE FINGER TOUCH TEST FOR CURSOR MISALIGNMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20155531 ↗
MalfunctionAug 28, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED AUTONOMOUS CURSOR MOVEMENT AFTER SOFTWARE UPDATE. MISALIGNMENT OF STYLUS AND CURSOR WAS NOTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20085845 ↗
MalfunctionAug 23, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER CURSOR WAS OBSERVED TO BE MOVING AUTONOMOUSLY AFTER A SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20046746 ↗
MalfunctionAug 20, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE CURSOR ON THE DISPLAY OF THE PROGRAMMER MOVED WITHOUT INPUT AFTER THE RECENT SOFTWARE UPDATE WITH THE UPDATE UNIVERSAL SERIAL BUS (USB) DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20002511 ↗
MalfunctionAug 16, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER WAS EXPERIENCING THE AUTONOMOUS CURSOR MOVEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19998457 ↗
MalfunctionAug 14, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE PROGRAMMER WAS RETURNED AS PART OF AN INVENTORY REDUCTION INITIATIVE AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19981461 ↗
MalfunctionAug 7, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER CURSOR WAS OBSERVED TO BE MOVING AUTONOMOUSLY POST UPDATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19927958 ↗
MalfunctionAug 7, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER FAILED A TOUCHSCREEN TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19927941 ↗
MalfunctionFeb 20, 2024No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER'S CURSOR MOVED AUTONOMOUSLY INTERMITTENTLY. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE PERFORMING A CALIBRATION OF THE PROGRAMMER'S STYLUS WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18738076 ↗
MalfunctionOct 16, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem
THE PROGRAMMER WAS RETURNED AS PART OF AN INVENTORY REDUCTION INITIATIVE AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17937634 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P890003. One submission often covers many models, so check the product and lot details in each record.

Z-2169-2025 · Jun 18, 2025 · Open, Classified
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria A
Z-2168-2025 · Jun 18, 2025 · Open, Classified
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria
Z-2127-2025 · Jun 17, 2025 · Open, Classified
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D
Z-2128-2025 · Jun 17, 2025 · Open, Classified
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model N
Z-2506-2020 · Jun 4, 2020 · Open, Classified
Patient Connector, Model Number 24967
Z-2505-2020 · Jun 4, 2020 · Open, Classified
CareLink SmartSync Device Manager, Model Number 24970A
Z-0845-2019 · Jan 17, 2019 · Terminated
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Z-0400-2018 · Jul 14, 2017 · Terminated
MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates
Z-0399-2018 · Jul 14, 2017 · Terminated
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with
Z-2209-2010 · Jun 11, 2010 · Terminated
Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic w

Device details

UDI-DI	`00613994175403`
Brand	Medtronic CareLink® Programmer
Model	2090
Company	Medtronic, Inc.
Product code	KRG · Programmer, pacemaker
Class	Class 3
FDA submission	P890003
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Cardiac pulse generator programmer

An external device intended to enable a healthcare professional in a clinical setting to noninvasively change the settings of, and extract data from, an implanted cardiac pulse generator (e.g., pacemaker, pacemaker/defibrillator). It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software.

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All Programmer, pacemaker devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page