Medtronic CareLink® Programmer 2090W (UDI 00885074301440)Recalls & reported problems

Medtronic, Inc. · PROGRAMMER 2090W TELEMETRY C US · 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 2090W is a programmer used to communicate with pacemakers. Its 489 reports most often describe display problems and operating system faults. The reports include 6 injuries and no deaths. There are 3 recalls, 2 still open, covering a touchscreen that moves the cursor by itself and cyber security weaknesses. Reports fell from 30 the year before to 2 in the latest year.

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: 489
Deaths reported: 0
Injuries reported: 6
Recalls naming it: 3

Summary

The FDA's MAUDE database contains 489 adverse event reports that list this exact device (DI 00885074301440), received between Apr 6, 2017 and Aug 26, 2026 — classified as 6 injuries, 483 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (132 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 Problem132
Computer Operating System Problem95
Device Difficult to Program or Calibrate87
No Display/Image81
Computer Software Problem61
Overheating of Device56
Output Problem48
Unexpected Shutdown35

Patient problems

No Clinical Signs, Symptoms or Conditions287
No Patient Involvement97
No Known Impact Or Consequence To Patient96
No Consequences Or Impact To Patient7
Anxiety1
Cardiac Arrest1
Loss of consciousness1
Shock from Patient Lead(s)1

Recent adverse event reports

The 25 most recent of 489 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 26, 2026Mechanical Problem; Overheating of Device
It was reported that the programmer was overheated, which damaged the Universal Serial Bus (USB). It was noted that the lid was unable to stay open. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50449867 ↗
MalfunctionMar 31, 2026Display 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 24739417 ↗
MalfunctionAug 8, 2025Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate
IT IT WAS REPORTED THAT THE PROGRAMMER'S DISPLAY WAS UNABLE TO RESPOND PROPERLY TO THE STYLUS WHEN ATTEMPTING TO USE IT. TROUBLESHOOTING STEPS WERE TAKEN, INCLUDING INSTALLING A NEW STYLUS AND RUNNING THE SETUP PROTOCOL, BUT IT WAS NOTED THAT THIS WAS DIFFICULT DUE TO A LACK OF CURSOR RESPONSIVENESS TO THE STYLUS. A FURTHER TROUBLESHOOTING STEP WAS TAKEN, WHICH INCLUDED THE INSTALLATION OF THE LATEST SOFTWARE UPDATE, BUT AFTER THE UPDATE, IT WAS NOTED THAT THE CURSOR BEGAN TO MOVE AUTONOMOUSLY WITHOUT ANY TOUCH INPUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22746972 ↗
MalfunctionJul 10, 2025Display 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 22466727 ↗
MalfunctionJun 25, 2025Display 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 22326176 ↗
MalfunctionJun 25, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER DEMONSTRATED THE AUTONOMOUS CURSOR MOVEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22325472 ↗
MalfunctionMay 24, 2025Computer Software Problem; Display or Visual Feedback Problem; Problem with Software Installation; Computer Software Problem; Display or Visual Feedback Problem; Problem with Software Installation
IT WAS REPORTED THAT THE PROGRAMMER GENERATED AN ERROR CODE DURING A SOFTWARE UPDATE. TROUBLESHOOTING STEPS WERE TAKEN TO REBOOT THE DEVICE TWICE. THE PROGRAMMER HAS BEEN RETURNED FOR EVALUATION 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 22082051 ↗
MalfunctionMay 5, 2025Display 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 21958902 ↗
MalfunctionMay 5, 2025Computer Software Problem; No Display/Image; Display or Visual Feedback Problem; Computer Software Problem; No Display/Image; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED A BLACK SCREEN THAT DISPLAYED A DIAGNOSTIC MESSAGE SAYING "SERIOUS PROGRAMMER ERROR". TROUBLESHOOTING STEPS WERE TAKEN TO POWER CYCLE THE PROGRAMMER AFTER WHICH IT CLEARED THE BLACK SCREEN. THE PROGRAMMER HAS BEEN RETURNED FOR EVALUATION 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 21958795 ↗
MalfunctionApr 18, 2025Display 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 21866055 ↗
MalfunctionMar 13, 2025Display or Visual Feedback Problem; Noise, Audible; Display or Visual Feedback Problem; Noise, Audible
IT WAS REPORTED THAT THE PROGRAMMER DEMONSTRATED AUTONOMOUS CURSOR MOVEMENT AS THE CURSOR WAS MOVING AROUND THE SCREEN ON ITS OWN WITHOUT USER INPUT AFTER THE MOST RECENT SOFTWARE UPDATE. IT WAS NOTED THAT THE PROGRAMMER BEGAN TO BEEP REPEATEDLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21591932 ↗
MalfunctionMar 6, 2025No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER DEMONSTRATED AUTONOMOUS CURSOR MOVEMENT WHEN ATTEMPTING TO INTERROGATE A CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED). IT WAS NOTED THAT THE TOUCHSCREEN WAS TOO SENSITIVE AND THE CURSOR WAS SELF-CLICKING ON DIFFERENT PARTS OF THE TOUCHSCREEN AFTER THE MOST RECENT SOFTWARE UPDATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21534741 ↗
MalfunctionFeb 11, 2025Display 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 21356089 ↗
MalfunctionFeb 4, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER DEMONSTRATED AUTONOMOUS CURSOR MOVEMENT POST THE RECENT SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21301943 ↗
MalfunctionFeb 4, 2025Computer Software Problem; Computer Operating System Problem; Computer Software Problem; Computer Operating System Problem
IT WAS REPORTED THAT THE PROGRAMMER CRASHED WHILE INTERROGATING THE DEVICE DURING A SCHEDULED DEVICE CHECK. IT WAS NOTED THAT THE BLACK SCREEN APPEARED WITH THE ERRORS "SYSTEM ERROR" AND "SERIOUS PROGRAMMER PROBLEM". TROUBLESHOOTING STEPS WERE TAKEN TO REBOOT THE DEVICE BUT THE ISSUE PERSISTED, INTERROGATION WAS COMPLETED WITH AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21301904 ↗
MalfunctionJan 23, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED INAPPROPRIATE CURSOR MOVEMENT FOLLOWING A SOFTWARE UPDATE. IT WAS ALSO REPORTED THAT THE PROGRAMMER CURSOR WOULD JUMP TO DIFFERENT PARTS OF THE PROGRAMMER SCREEN DURING COMPLETION OF THE FINGER TOUCH TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21216237 ↗
MalfunctionJan 22, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER FAILED THE TOUCHSCREEN TEST FOR AUTONOMOUS CURSOR MOVEMENT FOLLOWING A SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21208991 ↗
MalfunctionJan 22, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER DEMONSTRATED AUTONOMOUS CURSOR MOVEMENT AFTER THE MOST RECENT SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21208271 ↗
MalfunctionDec 12, 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 20911769 ↗
MalfunctionDec 5, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED THE AUTONOMOUS CURSOR MOVEMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20851301 ↗
MalfunctionDec 4, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED A "GHOST CURSOR" WHEN POWERED UP AFTER THE SOFTWARE UPDATE. IT WAS NOTED THAT THERE WAS AUTONOMOUS CURSOR MOVEMENT DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20842761 ↗
MalfunctionDec 3, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE PROGRAMMER CURSOR WAS MISALIGNED FROM FINGER TOUCH FOLLOWING A SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20832177 ↗
MalfunctionNov 28, 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 20804520 ↗
MalfunctionNov 27, 2024Computer Software Problem; No Display/Image; Overheating of Device; Device Difficult to Program or Calibrate; Unexpected Shutdown; Computer Software Problem; No Display/Image; Overheating of Device; Device Difficult to Program or Calibrate; Unexpected Shutdown
IT WAS REPORTED THAT PROGRAMMER INTERMITTENTLY DISPLAYED AN ERROR MESSAGE INDICATED THAT THE PROGRAMMER WAS OVERHEATING AND NEED TO BE SHUT DOWN, OR IT SPONTANEOUSLY SHUT DOWN. IT WAS ALSO NOTED THAT THE PROGRAMMER WAS UNRESPONSIVE TO STYLUS INPUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20797850 ↗
MalfunctionNov 22, 2024Display 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 20756146 ↗

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-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-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-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-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-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-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	`00885074301440`
Brand	Medtronic CareLink® Programmer
Model	2090W
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	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