Medtronic CareLink® Programmer 2090AA4Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00721902824692), received between Jun 8, 2017 and Sep 2, 2026 — classified as 1 injury, 81 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (33 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 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026No Display/Image; Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50560725 ↗
• MalfunctionApr 28, 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 25012162 ↗
• MalfunctionApr 20, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED AUTONOMOUS CURSOR MOVEMENT ON THE HOME SCREEN ¿FIND PATIENT.¿ THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926471 ↗
• MalfunctionApr 11, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED AUTONOMOUS CURSOR BEHAVIOR AND CLICKED ON THE SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849526 ↗
• MalfunctionFeb 13, 2026Display or Visual Feedback Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330512 ↗
• MalfunctionFeb 3, 2026Display 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 24247111 ↗
• MalfunctionJan 22, 2026Display or Visual Feedback Problem

  IT WAS FURTHER NOTED 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 24143692 ↗
• MalfunctionJan 22, 2026Display 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 24143659 ↗
• MalfunctionJan 8, 2026Display or Visual Feedback Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000817 ↗
• MalfunctionJan 7, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER'S SOFTWARE WAS UPDATED VIA UNIVERSAL SERIAL BUS (USB); HOWEVER, FAILED THE TOUCH SCREEN TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987832 ↗
• MalfunctionDec 11, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778598 ↗
• InjurySep 18, 2025Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PROGRAMMER DELIVERED A SHOCK TO THE PATIENT DURING IMPLANTABLE DEVICE INTERROGATION. THE PROCESS BEGAN WHEN THE RADIOFREQUENCY (RF) HEAD WAS PLACED ON THE DEVICE. AFTER THE FIRST TONE, IT WAS ASSUMED THAT WIRELESS TELEMETRY HAD BEEN ESTABLISHED, LEADING TO THE REMOVAL OF THE RF HEAD. HOWEVER, THE PROGRAMMER WAS NOT ENABLED FOR WIRELESS, THE RF HEAD WAS THEN PLACED BACK ON THE DEVICE, AND DURING THIS TIME, THE VVI EMERGENCY BUTTON WAS INADVERTENTLY PRESSED. ADDITIONALLY, EITHER THE "I" OR "P" BUTTON ON THE RF HEAD WAS ACTIVATED, WHICH TRIGGERED THE DELIVERY OF A SHOCK. THE RF HEAD WAS IMMEDIATELY REMOVED, AND THE SESSION WAS ENDED. UPON REINTERROGATION, THE EMERGENCY DEFIBRILLATION SCREEN APPEARED, WHICH WAS EXITED, AND CARE FOR THE PATIENT CONTINUED. THE PATIENT WAS STARTLED BUT REMAINED CONSCIOUS, WITH NO INJURIES NOTED. THEY WERE EVALUATED THE SAME DAY AND REPORTED FEELING FINE. A CARELINK TRANSMISSION SENT THE FOLLOWING DAY CONFIRMED THAT HIGH-VOLTAGE THERAPY HAD BEEN DELIVERED. IT WAS ALSO OBSERVED THAT THE PROGRAMMER MAY HAVE EXHIBITED SIGNS OF AUTONOMOUS CURSOR MOVEMENT. TROUBLESHOOTING STEPS WERE TAKEN TO REPRODUCE THE ISSUE, BUT THE BEHAVIOR COULD N

  Patient problems: Shock

  MAUDE report 23081928 ↗
• MalfunctionSep 17, 2025Computer Software Problem; No Display/Image; Problem with Software Installation; Computer Software Problem; No Display/Image; Problem with Software Installation

  IT WAS REPORTED THAT THE PROGRAMMER'S TOUCHSCREEN WAS NON-FUNCTIONAL. ADDITIONALLY, THE DEVICE WAS UNABLE TO UPDATE VIA THE SOFTWARE DISTRIBUTION NETWORK (SDN), DISPLAYING AN ERROR MESSAGE STATING THAT NO UPDATES WERE AVAILABLE. IT WAS NOTED THAT THE PROGRAMMER STYLUS WAS GREY IN COLOR AND FUNCTIONING PROPERLY, DESPITE THE TOUCHSCREEN ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070657 ↗
• MalfunctionAug 11, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER SPONTANEOUSLY SHUT DOWN TWICE DURING INTERROGATION OF THE IMPLANTABLE DEVICE, WITH THE INCIDENTS OCCURRING A FEW HOURS APART. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22769002 ↗
• MalfunctionMay 1, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER FAILED THE TOUCHSCREEN TEST FOR FINGER TOUCH MISALIGNMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941004 ↗
• MalfunctionMar 5, 2025Computer Operating System Problem; Operating System Becomes Nonfunctional; Computer Operating System Problem; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PROGRAMMER CRASHED AND FROZE. TROUBLESHOOTING STEPS WERE PERFORMED WHICH INCLUDED DELETING THE PROTECTED HEALTH INFORMATION (PHI) AND PERFORMING A HARD REBOOT 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 21524640 ↗
• MalfunctionNov 27, 2024Display or Visual Feedback Problem; Output Problem; Display or Visual Feedback Problem; Output Problem

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AUTONOMOUS CURSOR MOVEMENT AND THE CURSOR JUMPED AROUND THE SCREEN. IT WAS NOTED THAT THE PROGRAMMER HAD PRINTER ISSUES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795864 ↗
• MalfunctionNov 19, 2024Display 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 20722343 ↗
• MalfunctionOct 29, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER WAS BEEPING AND EXHIBITED AUTONOMOUS CURSOR MOVEMENT FOLLOWING A SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556091 ↗
• MalfunctionOct 17, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER CURSOR WAS MOVING AUTONOMOUSLY AFTER A SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471341 ↗
• MalfunctionOct 10, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416826 ↗
• MalfunctionOct 8, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER FAILED THE FINGER TOUCH TEST EXHIBITING CURSOR/TOUCH MISALIGNMENT AND AUTONOMOUS MOVEMENT OF THE CURSOR WAS OBSERVED AFTER SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396050 ↗
• MalfunctionOct 8, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AUTONOMOUS CURSOR MOVEMENT DURING AN ASSESSMENT AFTER A SOFTWARE UPDATE. IT WAS NOTED THAT THE CURSOR MOVED WITHOUT USER INPUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20394372 ↗
• MalfunctionSep 30, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER CURSOR WAS OBSERVED TO BE MOVING AND SELECTING AUTONOMOUSLY ON THE DISPLAY SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20331773 ↗
• MalfunctionSep 20, 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 20265657 ↗

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-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-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-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-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-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