Medtronic CareLink® Programmer 2090 (UDI 00613994581570)Recalls & reported problems

Summary

The FDA's MAUDE database contains 559 adverse event reports that list this exact device (DI 00613994581570), received between Apr 6, 2017 and Aug 31, 2026 — classified as 2 injuries, 557 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (315 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 559 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Display or Visual Feedback Problem; Device Difficult to Program or Calibrate

  It was reported that the programmers cursor position was offset from the position of stylus and the cursor moved autonomously. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525191 ↗
• MalfunctionApr 1, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE EMERGENCY OPTION WAS INADVERTENTLY SELECTED ON THE PROGRAMMER. IT WAS NOTED THAT ALTHOUGH 'NO' WAS CHOSEN AT THE CONFIRMATION PROMPT, THE PROGRAMMER CHANGED SETTINGS TO EMERGENCY SETTINGS REGARDLESS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24751494 ↗
• MalfunctionNov 25, 2025No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER¿S TOUCHSCREEN WAS UNRESPONSIVE TO FINGER TOUCH. IT WAS NOTED THAT THE LATEST SOFTWARE WAS UPDATED, BUT FINGER TOUCH WAS UNABLE TO WORK. IT WAS ALSO REPORTED THAT THE PROGRAMMER'S CURSOR MOVED ON ITS OWN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23653398 ↗
• MalfunctionSep 8, 2025Computer Software Problem; No Display/Image; Data Problem; Computer Software Problem; No Display/Image; Data Problem

  IT WAS REPORTED THAT DURING A NEWLY IMPLANTED LEAD TEST WHILE USING THE PROGRAMMER ANALYZER, IT WAS OBSERVED THAT THE PROGRAMMER SCREEN WAS FLASHING WHEN THE RATE WAS SELECTED FOR ADJUSTMENT. THIS OCCURRED MULTIPLE TIMES BEFORE THE USER COULD SUCCESSFULLY CHANGE THE RATE. ADDITIONALLY, AT ONE POINT, THE SLEW RATE AND P WAVE BOX NAMES DISAPPEARED FROM THE PROGRAMMER'S DISPLAY. DESPITE THESE CHALLENGES, THE TESTING WAS EVENTUALLY COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992705 ↗
• MalfunctionNov 11, 2024Material Integrity Problem; Unexpected Shutdown; Material Integrity Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER HAD A BROKEN LATCH. 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 20650190 ↗
• MalfunctionOct 29, 2024Corroded; No Display/Image; Corroded; No Display/Image

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED A BLACK SCREEN. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE A SOFT RESET ATTEMPT BUT THE ISSUE PERSISTED. 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 20558570 ↗
• MalfunctionAug 15, 2024No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER'S CURSOR DISPLAYED A 'FLOATING' ACTION POST SOFTWARE UPDATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990191 ↗
• MalfunctionJul 24, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO STAY POWERED ON. IT WAS FURTHER REPORTED THAT THE RADIOFREQUENCY (RF) HEAD 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 19817717 ↗
• MalfunctionJun 13, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PROGRAMMER RELEASED SMOKE WHEN TURNED ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19530320 ↗
• MalfunctionMar 28, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE PROGRAMMER'S STYLUS WAS FAULTY. TROUBLESHOOTING STEPS WERE ADVISED TO INCLUDE RECALIBRATING THE STYLUS WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994418 ↗
• MalfunctionMar 25, 2024Computer Software Problem; Display or Visual Feedback Problem; Computer Operating System Problem; Computer Software Problem; Display or Visual Feedback Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER WAS SLUGGISH IN BOOTING AND SENDING TO UNIVERSAL SERIAL BUS (USB). IT WAS ALSO NOTED THAT THE PROGRAMMER GENERATED AN ERROR. 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 18966980 ↗
• MalfunctionMar 6, 2024Display or Visual Feedback Problem; Failure to Calibrate; Display or Visual Feedback Problem; Failure to Calibrate

  IT WAS REPORTED THAT THE PROGRAMMER'S STYLUS WAS MISALIGNED WITH THE ON SCREEN CURSOR AND PROGRAMMING WAS NOT POSSIBLE. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE PERFORMING A CALIBRATION OF THE STYLUS HOWEVER THE ISSUE REMAINED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844583 ↗
• MalfunctionFeb 21, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE PROGRAMMER SCREEN WAS UNRESPONSIVE TO TOUCH IN THE TOP LEFT CORNER. IT WAS NOTED THAT REST OF THE SCREEN OPERATED PROPERLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18746334 ↗
• MalfunctionFeb 13, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE PROGRAMMERS DISPLAY WAS NOT WORKING. THE PROGRAMMER WAS RETURNED FOR EVALUATION. THERE WAS NO PATIENT INVOL VEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695853 ↗
• MalfunctionDec 19, 2023No Display/Image; Failure to Interrogate; Connection Problem; Problem with Software Installation; No Display/Image; Failure to Interrogate; Connection Problem; Problem with Software Installation

  IT WAS REPORTED THAT THE PROGRAMMER'S TOUCHSCREEN WAS UNABLE TO WORK BY BOTH STYLUS AND FINGER TOUCH. IT WAS NOTED THAT THE HIGH SPEED CONNECTOR WAS UNABLE TO CONNECT TO THE INTERNET, HOWEVER USING A NETWORK CARD RESOLVED THE ISSUE. IT WAS FURTHER NOTED THAT THE PROGRAMMER WAS UNABLE TO INTERROGATE THE IMPLANTABLE CARDIAC DEVICE, HOWEVER AN ALTERNATIVE MOBILE PROGRAMMER WAS ABLE TO INTERROGATE WITHOUT ISSUE. FURTHERMORE, THE PROGRAMMER WAS UNABLE TO BE UPDATED VIA THE SOFTWARE DISTRIBUTION NETWORK (SDN). TROUBLESHOOTING STEPS WERE TAKEN TO SWITCH OUT THE RADIO FREQUENCY (RF) HEAD HOWEVER THE ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18355317 ↗
• MalfunctionDec 8, 2023No Display/Image; Device Difficult to Program or Calibrate; Failure to Calibrate; No Display/Image; Device Difficult to Program or Calibrate; Failure to Calibrate

  IT WAS FURTHER REPORTED THAT IT WAS NOT POSSIBLE TO CALIBRATE THE PROGRAMMER TOUCHSCREEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18289485 ↗
• MalfunctionNov 17, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMERS STYLUS WAS NOT CALIBRATING WITH THE DISPLAY. THE CURSOR WAS NOTED TO BE OFF BY 1.5 INCHES. ANOTHER STYLUS WAS USED AND THE DISPLAY WAS RECALIBRATED BUT THE ISSUE REMAINED. THE PROGRAMMER WAS RETURNED FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159306 ↗
• MalfunctionOct 25, 2023No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003087 ↗
• MalfunctionOct 9, 2023Display 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 17894665 ↗
• MalfunctionOct 5, 2023No Display/Image; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Failure to Calibrate; No Display/Image; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT THE STYLUS DID NOT TRACK CORRECTLY WITH THE CURSOR ON THE PROGRAMMER SCREEN. CALIBRATION FAILED TO RESOLVE THE ISSUE. THE PROGRAMMER HAS BEEN RECEIVED IN FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17875150 ↗
• MalfunctionSep 21, 2023Failure to Power Up; Unexpected Shutdown; Failure to Power Up; Unexpected Shutdown

  IT WAS NOTED THAT CHANGING OUT THE POWER CORD AND POWER OUTLET FAILED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17787144 ↗
• MalfunctionAug 30, 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 17648929 ↗
• MalfunctionAug 23, 2023Computer Operating System Problem; Unexpected Shutdown; Computer Operating System Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER REBOOTS AND FREEZES UP. THE PROGRAMMER WAS RETURNED FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17603385 ↗
• MalfunctionAug 21, 2023Device Difficult to Program or Calibrate; Connection Problem; Device Difficult to Program or Calibrate; Connection Problem

  IT WAS REPORTED THAT THE STYLUS CONNECTOR OF THE PROGRAMMER WAS DEFECTIVE. IT WAS NOTED THAT THE STYLUS WAS REPLACED HOWEVER, THE ISSUE REMAINED. IT WAS FURTHER NOTED THAT BOTH STYLUSES WORKED WHEN USED WITH ANOTHER PROGRAMMER. 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 17582285 ↗
• MalfunctionAug 9, 2023Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO BE CALIBRATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17490979 ↗

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