Medtronic CareLink® Programmer 2090 (UDI 00613994175397)Recalls & reported problems

Summary

The FDA's MAUDE database contains 422 adverse event reports that list this exact device (DI 00613994175397), received between May 15, 2017 and Jul 29, 2026 — classified as 4 injuries, 418 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (95 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 422 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50065913 ↗
• MalfunctionJun 9, 2026Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT THE PROGRAMMER'S CURSOR WAS LAGGING AND OCCASIONALLY JUMPING AND WAS UNABLE TO MAKE EXACT SELECTIONS ON THE SCR EEN WHEN USING FINGER TOUCH. IT WAS ALSO NOTED THAT THE TOUCHSCREEN WAS UNABLE TO BE CALIBRATED AND THAT THE STYLUS WAS COMPLETELY UNABLE TO FUNCTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25438990 ↗
• MalfunctionMar 18, 2026Computer Software Problem; Display or Visual Feedback Problem; Computer Operating System Problem; Noise, Audible

  IT WAS REPORTED THAT THE PROGRAMMER DEMONSTRATED AUTONOMOUS CURSOR MOVEMENT AND WAS UNABLE TO CONTROL THE CURSOR, CAUSING IT TO FREEZE AND BEGIN TO BEEP. TROUBLESHOOTING STEPS WERE TAKEN, INCLUDING TURNING THE DEVICE OFF AND THEN ON AGAIN, AND AN ERROR MESSAGE WAS DISPLAYED. IT WAS NOTED THAT FURTHER TROUBLESHOOTING STEPS WERE TAKEN, INCLUDING SWITCHING TO ANOTHER PROGRAMMER, WHICH FUNCTIONED PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630610 ↗
• MalfunctionMar 10, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER SHUT DOWN WHILE INTERROGATING AN IMPLANTABLE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559982 ↗
• MalfunctionMar 4, 2026Display or Visual Feedback Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511045 ↗
• MalfunctionJan 19, 2026Break; Display or Visual Feedback Problem; Component Missing; Noise, Audible

  IT WAS REPORTED THAT THE PROGRAMMER EXHIBITED AUTONOMOUS CURSOR MOVEMENT AND FAILED THE FINGER TOUCH TEST DUE TO CURSOR MISALIGNMENT AND JUMPING. IT WAS ALSO NOTED THAT THE CORD COMPARTMENT COVER WAS BROKEN AND WAS UNABLE TO LATCH, AND THAT THE POWER CORD WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24106887 ↗
• MalfunctionJan 5, 2026Display or Visual Feedback Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955828 ↗
• MalfunctionNov 11, 2025Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate

  IT WAS FURTHER NOTED THAT THE DISPLAY WAS MISALIGNED WITH THE STYLUS TOUCH INPUT, CAUSING THE CURSOR TO NOT LAND IN THE INTENDED AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520213 ↗
• MalfunctionNov 4, 2025Electrical /Electronic Property Problem; Failure to Interrogate; Electrical /Electronic Property Problem; Failure to Interrogate

  IT WAS REPORTED THAT THE PROGRAMMER'S EMERGENCY VVI (VENTRICULAR PACED, VENTRICULAR SENSED, AND INHIBITED) PACING WAS ACTIVATED WITHOUT THE BUTTON BEING PRESSED. IT WAS ALSO NOTED THAT IT WAS UNABLE TO INTERROGATE IMPLANTABLE DEVICES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464357 ↗
• MalfunctionOct 20, 2025Failure to Interrogate; Mechanical Problem; Device Emits Odor; Failure to Interrogate; Mechanical Problem; Device Emits Odor

  IT WAS REPORTED THAT THE PROGRAMMER¿S FAN EMITTED A BURNING SMELL AND WAS UNABLE TO INTERROGATE A SPECIFIC IMPLANTABLE DEVICE. 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 23334259 ↗
• MalfunctionJul 16, 2025Computer Software Problem; Inadequate User Interface; Computer Software Problem; Inadequate User Interface

  IT WAS REPORTED THAT THE PROGRAMMER GENERATED AN ERROR MESSAGE INDICATING ¿PROGRAMMER HAS LOST COMMUNICATION WITH ANALYZER,¿ WHICH RESULTED IN THE ANALYZER BEING UNABLE TO START UP. TROUBLESHOOTING STEPS WERE TAKEN, INCLUDING CHECKING THE CONNECTION AND CHANGING THE 9 VOLT (V) BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519168 ↗
• MalfunctionJun 30, 2025Overheating of Device; Failure to Power Up; Overheating of Device; Failure to Power Up

  IT WAS REPORTED THAT THE PROGRAMMER EMITTED A BURNING SMELL AND WAS UNABLE TO TURN ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356118 ↗
• MalfunctionMay 26, 2025Display 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 22084368 ↗
• MalfunctionMay 8, 2025No Display/Image; Computer Operating System Problem; No Display/Image; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER FROZE TWICE WHILE SETTING UP FOR DEVICE IMPLANTATION ON THE ANALYZER SCREEN. AFTER THE FIRST FREEZE, THE PROGRAMMER WAS TURNED OFF AND THEN RESTARTED. HOWEVER, IT FROZE AGAIN AFTER A FEW MINUTES. A DIFFERENT PROGRAMMER WAS USED FOR THE PROCEDURE, AND AFTER COMPLETION, THE ORIGINAL PROGRAMMER WAS TURNED ON TO A BLACK SCREEN. TROUBLESHOOTING STEPS WERE ATTEMPTED, INCLUDING A HARD REBOOT, BUT THE PROGRAMMER FAILED TO TURN ON AND REMAINED STUCK ON THE BLACK SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21984111 ↗
• MalfunctionApr 30, 2025Computer Operating System Problem; Noise, Audible; Computer Operating System Problem; Noise, Audible

  IT WAS REPORTED THAT THE PROGRAMMER'S SCREEN FROZE AND THE CURSOR WAS UNABLE TO MOVE WHEN IT WAS TURNED ON ACCOMPANIED BY A BEEPING NOISE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934067 ↗
• MalfunctionMar 28, 2025Electrical /Electronic Property Problem; Material Integrity Problem; Electrical /Electronic Property Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PROGRAMMER UNEXPECTEDLY DISPLAYED AN EMERGENCY PACING SCREEN TWICE DURING THE INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS NOTED THAT THE EMERGENCY SCREEN DISPLAY SPONTANEOUSLY WITHOUT PRESSING THE EMERGENCY BUTTON. IT WAS FURTHER NOTED THAT THE PROGRAMMER'S POWER CORD WAS FRAYED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718728 ↗
• 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 21592036 ↗
• MalfunctionFeb 21, 2025Computer Software Problem; Unexpected Shutdown; Computer Software Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER HAD SPONTANEOUSLY SHUTDOWN. IT WAS NOTED THAT WHEN ATTEMPTING TO USE THE ANALYZER, THE PROGRAMMER GENERATED AN ERROR MESSAGE INDICATING THAT THERE WAS A LOSS OF COMMUNICATION BETWEEN THE PROGRAMMER AND ANALYZER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431495 ↗
• MalfunctionJan 17, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO RESPOND TO THE FINGER TOUCH OR STYLUS. THE PROGRAMMER IS EXPECTED TO BE RETURNED FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178617 ↗
• MalfunctionJan 6, 2025Break; Display or Visual Feedback Problem; Computer Operating System Problem; Break; Display or Visual Feedback Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER WAS BROKEN. IT WAS NOTED THAT THE PROGRAMMER WAS LOADING REPEATEDLY AND THEREFORE UNABLE TO INTERROGATE IMPLANTABLE DEVICES. 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 21078940 ↗
• MalfunctionDec 10, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE PROGRAMMER WAS RETURNED AS PART OF AN INVENTORY REDUCTION INITIATIVE AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THE ANALYZER WAS RETURNED FOR EVALUATION 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 20892172 ↗
• MalfunctionNov 19, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER'S CURSOR WAS MISALIGNED FROM THE FINGER TOUCH AFTER THE SOFTWARE WAS UPDATED. IT WAS NOTED THAT THERE WAS ERRATIC MOVEMENT OBSERVED WHEN THE FINGER WENT ACROSS THE SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722369 ↗
• MalfunctionNov 19, 2024Break; Display or Visual Feedback Problem; Noise, Audible; Break; Display or Visual Feedback Problem; Noise, Audible

  IT WAS REPORTED THAT THE PROGRAMMER HAD DISPLAYED AUTONOMOUS CURSOR MOVEMENT AFTER THE SOFTWARE UPDATE AND AN ERRATIC CURSOR WAS OBSERVED. IT WAS NOTED THAT THE DOOR ON THE POWER CORD STORAGE BAY WAS BROKEN AND THE FAN WAS NOISY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722206 ↗
• MalfunctionNov 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 20664192 ↗
• MalfunctionNov 12, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER DID NOT PASS THE TOUCHSCREEN CHECK, AND THE CURSOR WAS MISALIGNED FROM THE FINGER TOUCH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20661783 ↗

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-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