Medtronic CareLink® Programmer 2090W (UDI 00613994127631)Recalls & reported problems

Summary

The FDA's MAUDE database contains 208 adverse event reports that list this exact device (DI 00613994127631), received between Apr 6, 2017 and Aug 31, 2026 — classified as 2 injuries, 206 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (53 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 208 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Unexpected Shutdown

  It was reported that the programmer powered on without the Radiofrequency(RF) head being connected and operated normally. When the RF head was connected, the programmer immediately powered off. The power switch was cycled with the RF head remaining connected; however, the programmer did not power on. The power cord was verified to be securely connected. The RF head was then disconnected, after which the programmer powered on and functioned normally. A different RF head was subsequently connected to the programmer, and the programmer continued to operate normally without powering off. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50517300 ↗
• MalfunctionApr 29, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER CURSOR FAILED TO FOLLOW FINGER TOUCH MOVEMENTS AND JUMPED AROUND, CLICKING AUTONOMOUSLY WITHOUT PROMPTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024850 ↗
• MalfunctionFeb 20, 2026No Display/Image

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAY WAS UNRESPONSIVE TO FINGER TOUCH AFTER THE SOFTWARE UPDATE AND WAS ABLE TO WORK WITH THE STYLUS PEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398144 ↗
• MalfunctionJan 27, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN ELECTRICAL SAFETY TEST, THE PROGRAMMER FAILED THE RESISTANCE PART. MULTIPLE DIFFERENT POWER CORDS WERE TRIED, BUT THE ISSUE STILL PERSISTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24187043 ↗
• MalfunctionDec 9, 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 23755978 ↗
• MalfunctionNov 12, 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 23529847 ↗
• MalfunctionNov 11, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520038 ↗
• MalfunctionSep 18, 2025Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE PROGRAMMER'S STYLUS WAS UNABLE TO WORK INTERMITTENTLY OR DID NOT TRACK. IT WAS ALSO NOTED THAT THE TOUCHSCREEN UPDATE FAILED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084299 ↗
• MalfunctionMar 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 21574041 ↗
• MalfunctionOct 31, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER WAS BEEPING AND THE CURSOR WAS AUTONOMOUSLY MOVING FROM THE UPPER LEFT-HAND CORNER OF THE SCREEN TO THE RIGHT-HAND CORNER, BACK AND FORTH, AND AT ONE POINT MOVED DOWN TO THE BOTTOM OF THE SCREEN BEFORE RETURNING TO THE TOP LEFT CORNER. EVENTUALLY, IT STOPPED AND REMAINED IN PLACE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20576483 ↗
• MalfunctionOct 9, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER FAILED THE TOUCH TEST FOR CURSOR MISALIGNMENT AFTER A SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20406095 ↗
• MalfunctionAug 26, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS FURTHER REPORTED THAT THE RADIOFREQUENCY (RF) HEAD WAS RETURNED FOR EVALUATION AS AN ASSOCIATE PRODUCT AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20062859 ↗
• MalfunctionAug 23, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER FAILED AN AUTONOMOUS CURSOR MOVEMENT TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049422 ↗
• MalfunctionAug 22, 2024Display or Visual Feedback Problem; Failure to Interrogate; Display or Visual Feedback Problem; Failure to Interrogate

  IT WAS REPORTED THAT THE PROGRAMMER FAILED THE TOUCHSCREEN TEST AFTER THE RECENT SOFTWARE UPDATE. IT WAS NOTED THAT THE PROGRAMMER ALSO HAD AN ISSUE WITH INTERROGATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031124 ↗
• MalfunctionAug 20, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER¿S CURSOR WAS MOVED AND JUMPED RANDOMLY WITHOUT BEING TOUCHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002210 ↗
• MalfunctionAug 8, 2024Signal Artifact/Noise; Display or Visual Feedback Problem; Signal Artifact/Noise; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER DEMONSTRATED AUTONOMOUS CURSOR MOVEMENT WITHOUT INPUT FROM EITHER THE STYLUS PEN OR FINGER TOUCH AFTER THE SOFTWARE UPDATE VIA A UNIVERSAL SERIAL BUS (USB). IT WAS NOTED THAT THERE WAS NOISE ON THE ELECTROCARDIOGRAM (EKG) PORT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940617 ↗
• MalfunctionJul 26, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER FAILED CURSOR TESTING FOLLOWING AN UPDATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19836148 ↗
• MalfunctionDec 12, 2023Overheating of Device; Connection Problem; Overheating of Device; Connection Problem

  IT WAS REPORTED THAT THE VIDEO GRAPHICS ARRAY (VGA) VIDEO OUTPUT OF THE PROGRAMMER DID NOT WORK. 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 18308968 ↗
• MalfunctionOct 24, 2023No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE PROGRAMMER SCREEN WOULD NOT RESPOND TO THE STYLUS, THE INCORRECT ITEMS WERE OPENED AND THE CURSOR JUMPED AROUND THE SCREEN. THE PROGRAMMER HAS BEEN RETURNED FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995634 ↗
• MalfunctionOct 13, 2023Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO RESPOND TO THE STYLUS. TROUBLESHOOTING STEPS INCLUDED A REBOOT OF THE PROGRAMMER AND RESETTING THE PROGRAMMER STYLUS PLUGIN WHICH RESOLVED THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17929386 ↗
• MalfunctionAug 18, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PROGRAMMER WHICH WAS RETURNED FOR PREVENTATIVE MAINTENANCE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17570519 ↗
• MalfunctionMay 9, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE PROGRAMMER SCREEN WAS NOT RESPONDING TO THE STYLUS BY THE HEART RATE NUMBERS AND THE NUMBERS COULD NOT BE CHANGED. THE PROGRAMMER WAS RETUNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16893797 ↗
• MalfunctionApr 24, 2023No Display/Image; No Display/Image

  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 16793558 ↗
• MalfunctionMar 31, 2023Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT THE PROGRAMMERS MOTOR WAS SMOKING AND HAD A BURNING SMELL. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16654457 ↗
• MalfunctionMar 21, 2023Overheating of Device; Failure to Power Up; Noise, Audible; Unexpected Shutdown; Overheating of Device; Failure to Power Up; Noise, Audible; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER MADE A NOISE AND SMOKE CAME OUT OF THE FAN AFTER POWERING ON. THE PROGRAMMER THEN POWERED OFF AND WAS UNABLE TO BE TURNED BACK ON. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584095 ↗

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-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