Medtronic CareLink® Programmer 2090 (UDI 00613994581594)Recalls & reported problems

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 00613994581594), received between Apr 6, 2017 and Apr 2, 2026 — classified as 2 injuries, 149 malfunctions.

The most frequently reported specific device problem is “Computer Operating System Problem” (41 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.

Recalls naming this device

1. 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 ↗

2. 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 ↗

3. 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

Recent adverse event reports

The 25 most recent of 151 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Computer Software Problem; No Display/Image

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AN ERROR CODE. TROUBLESHOOTING STEPS WERE TAKEN, INCLUDING REBOOTING THE PROGRAMMER A COUPLE OF TIMES, AND THE START PAGE WAS REACHED TO SEARCH FOR A PATIENT. HOWEVER, THE TOUCHSCREEN WAS NOT RESPONSIVE. FURTHER TROUBLESHOOTING STEPS WERE TAKEN, INCLUDING REBOOTING AGAIN, BUT THE TOUCHSCREEN REMAINED INOPERABLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764258 ↗
• MalfunctionMar 10, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER TURNS ITSELF OFF DURING USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555757 ↗
• MalfunctionJan 14, 2026No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE PROGRAMMER¿S TOUCHSCREEN WAS UNRESPONSIVE TO THE FINGER AND THE STYLUS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067328 ↗
• MalfunctionAug 13, 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 THE MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791910 ↗
• MalfunctionApr 30, 2025Data Problem; Noise, Audible; Unexpected Shutdown; Data Problem; Noise, Audible; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER'S SCREEN SHUT DOWN AND WAS BLACK. IT WAS NOTED THAT THE PROGRAMMER WAS UNABLE TO SAVE TO THE UNIVERSAL SERIAL BUS (USB) AND THE FAN WAS VERY LOUD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937084 ↗
• MalfunctionJan 7, 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 21092088 ↗
• MalfunctionJan 6, 2025No Display/Image; Noise, Audible; Unexpected Shutdown; No Display/Image; Noise, Audible; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER'S CURSOR ON THE SCREEN WAS UNRESPONSIVE TO BOTH THE STYLUS AND FINGER TOUCH. IT WAS NOTED THAT THE PROGRAMMER EMITTED A LOUD HUMMING NOISE. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE POWER CYCLING THE PROGRAMMER BUT THE ISSUE PERSISTED. AN ALTERNATIVE PROGRAMMER WAS USED TO PERFORM THE PROCEDURE. THE PROGRAMMER HAS BEEN RETURNED FOR EVALUATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. IT WAS FURTHER REPORTED THAT THE ANALYZER WAS RETURNED TO SERVICE AS AN ASSOCIATE PRODUCT 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 21079884 ↗
• MalfunctionDec 2, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED AUTONOMOUS CURSOR MOVEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817685 ↗
• MalfunctionNov 19, 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 20722853 ↗
• MalfunctionNov 12, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS FURTHER NOTED THAT THE CURSOR WAS UNRESPONSIVE TO FINGER TOUCH AND NOT MISALIGNED AS PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20661765 ↗
• MalfunctionNov 4, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AUTONOMOUS CURSOR MOVEMENT AFTER THE SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20596810 ↗
• MalfunctionOct 31, 2024Display or Visual Feedback Problem; Problem with Software Installation; Display or Visual Feedback Problem; Problem with Software Installation

  IT WAS REPORTED THAT THE PROGRAMMER FAILED THE SOFTWARE UPDATE. IT WAS NOTED THAT THE PROGRAMMER EXHIBITED AUTONOMOUS CURSOR MOVEMENT AND FAILED THE FINGER TOUCH TEST FOR CURSOR MISALIGNMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20576534 ↗
• MalfunctionOct 23, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER'S CURSOR MOVED AROUND THE SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20512939 ↗
• MalfunctionOct 9, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AUTONOMOUS CURSOR MOVEMENT AFTER THE MOST RECENT SOFTWARE UPDATE. IT WAS NOTED THAT THE CURSOR WAS JUMPING AROUND THE SCREEN AND PRESSING BUTTONS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406224 ↗
• MalfunctionSep 16, 2024Display or Visual Feedback Problem; Computer Operating System Problem; Display or Visual Feedback Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO BOOT UP. THE PROGRAMMER WAS 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 20222490 ↗
• MalfunctionAug 26, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER FAILED THE TOUCHSCREEN TEST FOR ABNORMAL CURSOR MOVEMENT AFTER THE RECENT SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062770 ↗
• MalfunctionAug 21, 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 20022142 ↗
• MalfunctionAug 9, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER FAILED THE TOUCHSCREEN ASSESSMENT AFTER THE SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19947201 ↗
• MalfunctionAug 8, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER HAD FAILED THE CURSOR TOUCHSCREEN ASSESSMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938164 ↗
• MalfunctionAug 7, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED AUTONOMOUS CURSOR MOVEMENTS AFTER THE MOST RECENT SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929900 ↗
• MalfunctionJan 9, 2024Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO BE CALIBRATED. THE PROGRAMMER WAS RETURNED FOR EVALUATION. THERE WAS NO PATIENT IN VOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18474087 ↗
• MalfunctionNov 22, 2023No Display/Image; Overheating of Device; No Display/Image; Overheating of Device

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAY WENT BLANK AND COULD NOT BE RECOVERED. A REBOOT OF THE PROGRAMMER RESOLVED THE ISSUE. IT WAS ALSO NOTED THAT THE ANALYZER FROZE. THE PROGRAMMER WAS 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 18189729 ↗
• MalfunctionNov 13, 2023Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  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 18118358 ↗
• MalfunctionNov 2, 2023Computer Software Problem; Failure to Interrogate; Overheating of Device; Computer Operating System Problem; Output Problem; Noise, Audible; Computer Software Problem; Failure to Interrogate; Overheating of Device; Computer Operating System Problem; Output Problem; Noise, Audible

  IT WAS REPORTED THAT THE PROGRAMMER WAS OVERHEATING AND NOISY. IT WAS FURTHER NOTED THAT THE PROGRAMMER WAS THEN UNABLE OR SLOW TO PRINT, SAVE TO MEDIA AND INTERROGATE. IT WAS NOTED THAT THE PROGRAMMER WAS SWITCHED OUT FOR A DIFFERENT PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18053981 ↗
• MalfunctionAug 21, 2023No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE PROGRAMMER STYLUS WAS NOT WORKING AND THAT THERE THE DISPLAY WOULD GO BLACK WHEN ATTEMPTING TO TURN ON. THE PROGRAMMER RETURNED FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584750 ↗

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-2505-2020 · Jun 4, 2020 · Open, Classified
  CareLink SmartSync Device Manager, Model Number 24970A
• Z-2506-2020 · Jun 4, 2020 · Open, Classified
  Patient Connector, Model Number 24967
• 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