CareLink Encore™ 29901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 474 adverse event reports that list this exact device (DI 00643169763548), received between Apr 6, 2017 and May 11, 2026 — classified as 3 injuries, 471 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (223 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-1525-2020 · Root cause: Software design · FDA record ↗

2. Jan 17, 2019Terminated

   The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient's condition and pacing system used. The Medtronic CareLink Encore 29901 programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron.

   Z-0796-2019 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 474 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Computer Software Problem; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PROGRAMMER CRASHED DURING THE INTERROGATION OF A PATIENT¿S IMPLANTABLE DEVICE AND DISPLAYED AN ERROR MESSAGE. IT WAS NOTED THAT THE SCREEN WENT BLACK AND THEN DISPLAYED AN ERROR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137402 ↗
• MalfunctionMay 7, 2026Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PROGRAMMER BECAME UNRESPONSIVE AND FROZE WHEN AN ERROR MESSAGE APPEARED ON THE SCREEN WHILE ATTEMPTING TO SAVE DATA TO A FLASH DRIVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25108393 ↗
• MalfunctionMay 6, 2026Computer Software Problem; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PROGRAMMER CRASHED DURING A PATIENT SESSION. IT WAS NOTED THAT AN ERROR MESSAGE INDICATING SERIOUS SOFTWARE PROBLEM WAS DISPLAYED AND KICKED OUT OF PATIENT SESSION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25091705 ↗
• MalfunctionMay 5, 2026Computer Software Problem; No Display/Image; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PROGRAMMER GENERATED AN ERROR MESSAGE INDICATING A SERIOUS SOFTWARE PROBLEM. IT WAS NOTED THAT WHEN THE PRO GRAMMER WAS TURNED ON TO DISABLE THE AUTO-PRINTING, IT FROZE AT THE FIND MODEL AND FIND PATIENT SCREEN. IT WAS UNABLE TO NAVIGATE TO ANYTHING ON THE SCREEN, AND THE PROGRAMMER BECAME UNRESPONSIVE TO FINGER TOUCH OR THE STYLUS PEN. TROUBLESHOOTING STEPS WERE TAKEN, INCLUDING REBOOTING THE PROGRAMMER AND TAKING THE BATTERY OUT, WHICH DID NOT RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083316 ↗
• MalfunctionMay 5, 2026Computer Software Problem; Failure to Interrogate; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PROGRAMMER FROZE AT FORMATTING REPORTS AND UNABLE TO PROCEED FURTHER WITH INTERROGATION. IT WAS ALSO NOTED THAT THE PROGRAMMER GENERATED A SOFTWARE ERROR AFTER BOOT UP WHEN ATTEMPTED INTERROGATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25076999 ↗
• MalfunctionMay 4, 2026Computer Software Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE USER REPORTED DIFFICULTY USING THE PROGRAMMER DURING A DEVICE FOLLOW-UP SESSION. THE USER SELECTED THE APPROPRIATE DEVICE MODEL AND INITIATED INTERROGATION, WHICH WAS SUCCESSFULLY COMPLETED. HOWEVER, THE PROGRAMMER DISPLAYED A PERSISTENT MESSAGE AT THE TOP OF THE SCREEN STATING, ¿SERIOUS SOFTWARE PROBLEM.¿ AN ADDITIONAL POP-UP MESSAGE APPEARED STATING, ¿QUICK LOOK FOLLOW UP GENERATING COMPLETE REPORT,¿ AT WHICH POINT THE SYSTEM FROZE. THE PROGRAMMER SUBSEQUENTLY RESUMED NORMAL FUNCTION AFTER A PERIOD OF TIME. IT WAS NOTED A SEPARATE MESSAGE WAS DISPLAYED INDICATING, ¿INCONSISTENT DATE AND TIME SETTINGS HAVE BEEN DETECTED ON THE PROGRAMMER. IT WAS CONFIRMED PROGRAMMER DATE AND TIME WERE ACCURATE. TROUBLESHOOTING STEPS WERE TAKEN TO CHECK THE SOFTWARE VERSION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25066106 ↗
• MalfunctionApr 21, 2026Computer Software Problem; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PROGRAMMER CRASHED WITH THE ERROR "SERIOUS SOFTWARE PROBLEM." TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING CHANGES TO SETTINGS, AND IT WAS CONFIRMED THAT IT WORKED AND WAS ABLE TO SAVE THE PORTABLE DIGITAL DOCUMENT (PDD) FILE TO SEND TO A DATA MANAGEMENT SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941936 ↗
• MalfunctionApr 16, 2026Computer Software Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED A ¿SERIOUS SOFTWARE PROBLEM¿ ERROR MESSAGE. IT WAS NOTED THAT THE PROGRAMMER PROMPTED THAT INCONSISTENT DATE AND TIME SETTINGS WERE DETECTED; HOWEVER, THE DATE AND TIME WERE CONFIRMED TO BE CORRECT. IT WAS FURTHER NOTED THAT DURING INTERROGATION, THE PROGRESS BAR COMPLETED, BUT THE PROGRAMMER REMAINED ON THE FORMATTING REPORT SCREEN FOR SEVERAL MINUTES AND SUBSEQUENTLY DISPLAYED A BLACK SCREEN WITH A SYSTEM ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894353 ↗
• MalfunctionApr 15, 2026Computer Software Problem; Communication or Transmission Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PROGRAMMER SCREEN WAS STUCK, THEN WENT TO A BLACK SCREEN DISPLAYING A SYSTEM ERROR WHEN IT WAS TRYING TO FORMAT REPORTS WHILE INTERROGATING, AN IMPLANTABLE DEVICE. IT WAS NOTED THAT WHEN THE SCREEN CAME BACK ON, IT DISPLAYED AN ERROR MESSAGE INDICATING "SERIOUS SOFTWARE PROBLEM." NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24883941 ↗
• MalfunctionApr 10, 2026Computer Software Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PROGRAMMER¿S SCREEN WAS FROZEN WITH A POP UP MESSAGE DISPLAYED INDICATING "FORMATTING REPORT, PLEASE WAIT." THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24842685 ↗
• MalfunctionApr 10, 2026Data Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PROGRAMMER FROZE WHILE GENERATING A REPORT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24842645 ↗
• MalfunctionApr 9, 2026Unstable Capture Threshold; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO RUN A THRESHOLD TEST AND SCREEN WAS FROZEN ON QUICK LOOK FOLLOW-UP REPORT. TROUBLESHOOTING STEPS WERE PERFORMED BY POWER CYCLING, REMOVED THE BACK UP BATTERY AND REMOVED THE POWER SUPPLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24827451 ↗
• MalfunctionApr 9, 2026Computer Software Problem; Operating System Becomes Nonfunctional

  IT WAS REPORTED THAT THE PROGRAMMER CRASHED DURING AN ACTIVE PATIENT SESSION AND DISPLAYED ERROR MESSAGE INDICATING SERIOUS PROGRAMMER PROBLEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824739 ↗
• MalfunctionMar 26, 2026Electrical Shorting

  IT WAS REPORTED THAT THE PROGRAMMER'S POWER PLUG WAS BROKEN, AND THE PROGRAMMER HAD A SHORT CIRCUIT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698007 ↗
• MalfunctionMar 17, 2026Overheating of Device; Date/Time-Related Software Problem

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AN OVERHEATING MESSAGE AND THAT THE DATE WAS INCORRECT. TROUBLESHOOTING STEPS WERE PROVIDED FOR RESOLVING THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615018 ↗
• MalfunctionJan 5, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER REBOOTED WHILE CHECKING WITH PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955900 ↗
• MalfunctionJan 5, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER REBOOTED WHILE CHECKING WITH PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955886 ↗
• MalfunctionAug 29, 2025Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER'S SCREEN FROZE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22920822 ↗
• MalfunctionJul 24, 2025Computer Software Problem; Failure to Interrogate; Computer Operating System Problem; Computer Software Problem; Failure to Interrogate; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER SCREEN FROZE AND BECAME UNRESPONSIVE WHILE TRYING TO INTERROGATE. IT WAS NOTED THAT AN ERROR MESSAGE WAS GENERATED ALONG WITH A BLACK SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585236 ↗
• MalfunctionDec 4, 2024Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER'S SCREEN WAS FROZEN AND RADIOFREQUENCY (RF) HEAD LIGHTS WERE RED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20841064 ↗
• MalfunctionNov 5, 2024Computer Operating System Problem; Problem with Software Installation; Computer Operating System Problem; Problem with Software Installation

  IT WAS REPORTED THAT THE PROGRAMMER'S SCREEN FROZE WHEN TRYING TO UPDATE THE SOFTWARE USING THE UNIVERSAL SERIAL BUS (USB). TROUBLESHOOTING STEPS WERE TAKEN TO REBOOT THE PROGRAMMER AND THE USB WAS PLUGGED IN, AFTER WHICH THE UPDATES CONTINUED INSTALLING. HOWEVER, THE SOFTWARE UPDATE WAS NOT SUCCESSFUL. 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 20608599 ↗
• MalfunctionOct 29, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE PROGRAMMER HAD TOUCHSCREEN ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556347 ↗
• MalfunctionOct 29, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE PROGRAMMER HAD TOUCHSCREEN ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20556275 ↗
• MalfunctionOct 10, 2024No Display/Image; Computer Operating System Problem; No Display/Image; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER FROZE ON START UP. 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 20414039 ↗
• MalfunctionOct 4, 2024No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED A BLACK SCREEN UPON START UP, AFTER THE PROGRAMMER WAS LEFT IDLE AND DURING INTERROGATION CHECKS. IT WAS NOTED THAT THE PROGRAMMER SOFTWARE HAD BEEN UPDATED AND THE ISSUE HAD 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 20366949 ↗

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-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-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