Medtronic CareLink® Programmer 2090 (UDI 00613994434937)Recalls & reported problems

Summary

The FDA's MAUDE database contains 198 adverse event reports that list this exact device (DI 00613994434937), received between Jun 8, 2017 and Sep 18, 2025 — classified as 1 injury, 197 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (123 reports).

2 FDA recall records name this device's identifier, 1 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

2. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 198 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PROGRAMMER EMITTED A BURNING SMELL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081849 ↗
• MalfunctionFeb 4, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER SHUT DOWN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301913 ↗
• MalfunctionJan 29, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER SPONTANEOUSLY SHUT DOWN ON ITS OWN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262990 ↗
• MalfunctionAug 8, 2024No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER CURSOR MOVED WITHOUT THE STYLUS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938369 ↗
• MalfunctionMay 10, 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 19284338 ↗
• MalfunctionJan 17, 2024Computer Software Problem; No Display/Image; Operating System Becomes Nonfunctional; Computer Software Problem; No Display/Image; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PROGRAMMER TOUCHSCREEN STOPPED WORKING. REBOOTING THE PROGRAMMER RESOLVED THE TOUCHSCREEN ISSUE. IT WAS FURTHER REPORTED THAT AFTER THE REBOOT, SESSION DATA TOOK ONE HOUR TO EXPORT. A SECOND SESSION DATA EXPORT TOOK TWO HOURS. THE PROGRAMMER CRASHED AND DISPLAYED AN ERROR MESSAGE AFTER THE SECOND DATA EXPORT. A HARD REBOOT OF THE PROGRAMMER WAS PERFORMED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525854 ↗
• MalfunctionJan 17, 2024Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE PROGRAMMER STYLUS WAS NOT WORKING. TROUBLESHOOTING INVOLVED RESEATING THE STYLUS PLUG-IN AND A HARD REBOOT OF THE PROGRAMMER HOWEVER THE ISSUE REMAINED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525716 ↗
• MalfunctionNov 21, 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 18180640 ↗
• MalfunctionSep 14, 2023No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE DISPLAY OF THE PROGRAMMER WAS FLICKERING. 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 17744307 ↗
• MalfunctionAug 10, 2023Display 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 PROGRAMMERS DISPLAY AND STYLUS WERE NOT ALIGNED. THE STYLUS WAS REPLACED AND CALIBRATED. THE PROGRAMMER WAS RETURNED FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17499740 ↗
• MalfunctionDec 22, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE PROGRAMMER WAS RETURNED AS IT WAS NO LONGER REQUIRED 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 16032900 ↗
• MalfunctionNov 25, 2022No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE PROGRAMMER'S STYLUS WAS UNABLE TO WORK. IT WAS NOTED THAT THE PROGRAMMERS DISPLAY SCREEN WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15864036 ↗
• MalfunctionNov 7, 2022No Display/Image; Unexpected Shutdown; No Display/Image; Unexpected Shutdown

  IT WAS REPORTED THAT WHEN THE PROGRAMMER WAS POWERED ON THE SCREEN TURNED BLACK AND LOST POWER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743896 ↗
• MalfunctionNov 3, 2022Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Failure to Calibrate; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT THE STYLUS OF THE PROGRAMMER DID NOT MATCH THE CURSOR PLACEMENT ON THE SCREEN AND THE USER WAS UNABLE TO FIX THE CALIBRATION ISSUE. THE USER ATTEMPTED A HARD REBOOT AND THEN RECALIBRATION BUT THE ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15723634 ↗
• MalfunctionNov 1, 2022Device Difficult to Program or Calibrate; Failure to Calibrate; Device Difficult to Program or Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT THE PROGRAMMER AND STYLUS WERE WAS UNABLE TO CALIBRATE. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708030 ↗
• MalfunctionAug 19, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PROGRAMMER WAS OVERHEATING. THE PROGRAMMER RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15257093 ↗
• MalfunctionJul 11, 2022No Display/Image; Use of Device Problem; Power Problem; No Display/Image; Use of Device Problem; Power Problem

  IT WAS REPORTED THAT THE PROGRAMMER WAS RETURNED FOR SERVICE 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 14975009 ↗
• MalfunctionJun 9, 2022Computer Software Problem; Device Difficult to Program or Calibrate; Computer Operating System Problem; Computer Software Problem; Device Difficult to Program or Calibrate; Computer Operating System Problem

  THE PROGRAMMER WHICH WAS RETURNED FOR SERVICING SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ASSESSMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14641705 ↗
• MalfunctionJun 7, 2022No Display/Image; Mechanical Problem; No Display/Image; Mechanical Problem

  IT WAS REPORTED THAT THE CORD COVER LID REQUIRED REPAIR. IT WAS NOTED THAT THE PROGRAMMER REQUIRED A SOFTWARE UPDATE. IT WAS NOTED THAT THE PROGRAMMER SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14617096 ↗
• MalfunctionApr 4, 2022Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER HAD TO BE POWERED OFF IN ORDER TO END SESSION AFTER THE INTERROGATION OF AN IMPLANTABLE DEVICE. THE PROGRAMMER WAS RETURNED FOR SERVICE AND SUBSEQUENTLY TESTED OUT-OF-SPECIFICATION DURING MANUFACTURERS ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13997730 ↗
• MalfunctionFeb 21, 2022No Display/Image; Device Difficult to Program or Calibrate; Failure to Calibrate; Computer Operating System Problem; No Display/Image; Device Difficult to Program or Calibrate; Failure to Calibrate; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER SCREEN FROZE AND THE STYLUS WAS NOT CALIBRATED. IT WAS NOTED THAT THE STYLUS WAS CHANGED OUT HOWEVER THE ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13567674 ↗
• MalfunctionFeb 14, 2022No 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 REPORTED THAT THE PROGRAMMER SCREEN WAS UNRESPONSIVE TO THE STYLUS. IT WAS NOTED THAT THE SCREEN WAS RECALIBRATED SEVERAL TIMES WITH TWO SEPARATE STYLUSES HOWEVER THE ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13522325 ↗
• MalfunctionJan 28, 2022Crack; No Display/Image; Crack; No Display/Image

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAY SCREEN WAS RESPONSIVE TO THE STYLUS ONLY IN THE LEFT LOWER CORNER OF THE SCREEN AND THE DISPLAY SCREEN WAS CRACKED WITH SHARDS OF GLASS OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13384640 ↗
• MalfunctionJan 12, 2022Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE PROGRAMMER STYLUS CONNECTORS PINS WERE DAMAGED. IT WAS SPECULATED THAT THE DAMAGE WAS DUE TO MISTREATMENT OF THE DEVICE. THE PROGRAMMER WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236720 ↗
• MalfunctionDec 14, 2021No Display/Image; Device Difficult to Program or Calibrate; Failure to Calibrate; Output Problem; No Display/Image; Device Difficult to Program or Calibrate; Failure to Calibrate; Output Problem

  IT WAS FURTHER REPORTED THAT PARTS OF THE PROGRAMMER SCREEN WERE NOT RESPONSIVE DURING AN INTERROGATION. IT WAS NOTED THAT THE PRINTER JAMMED REPEATEDLY AND THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001586 ↗

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