CareLink EncoreRecalls & reported problems across all models

We found 2 models of CareLink Encore by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 739 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and May 11, 2026 — classified as 5 injuries, 734 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (280 reports).

3 FDA recall records name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

CareLink Encore recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 30, 2020Class IIOpen, 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 · names 2 of these models · Recall details · FDA record ↗

2. Jan 17, 2019Class IITerminated

   There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer. A failure mode of the power supply has been found where an electrical short occurs on the low voltage direct current connector and results in the connector heating up, generating smoke, melting and in some cases disconnecting from the programmer.

   Z-0845-2019 · Root cause: Device Design · Recall details · FDA record ↗

3. Jan 17, 2019Class IITerminated

   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 · names 2 of these models · Recall details · FDA record ↗

Most reported CareLink Encore problems

CareLink Encore models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CareLink Encore™ 29901A

  Pacemaker/icd/crt non-implanted components
  2 recalls474 reports
• CareLink Encore™ 29901

  implantable pacemaker Pulse-generator
  3 recalls265 reports

Recent CareLink Encore adverse event reports

The 15 most recent reports across all models, 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 6, 2026Computer Software Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PROGRAMMER FROZE WHILE PROCESSING A REPORT AND AN ERROR MESSAGE APPEARED. TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING RESTARTING THE PROGRAMMER, SETTING THE CLOCK BACK BY ONE MONTH, TURNING THE PROGRAMMER OFF, REMOVING AND REINSERTING THE BATTERY, AND THEN TURNING IT BACK ON. AFTER THESE STEPS, THE PROGRAMMER WAS ABLE TO INTERROGATE AND PRINT THE REPORT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25091430 ↗
• 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 PROGRAMMER GENERATED A SERIOUS SOFTWARE PROBLEM ERROR MESSAGE AFTER INTERROGATION AND RESOLVED THE ISSUE AFTER REBOOTING. IT WAS NOTED THAT THE PROGRAMMER GENERATED AN OTHER ERROR INDICATING INCONSISTENT DATE AND TIME AND ALSO DISPLAYED ANOTHER MESSAGE INDICATING TO LOOK AT THE SOFTWARE FOR SOFTWARE UPDATED AND THEN UNABLE TO CLICK ON ANYTHING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25066556 ↗
• 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 11, 2026Computer Software Problem; Use of Device Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PROGRAMMER FROZE AND DISPLAYED AN ERROR MESSAGE STATING ¿SERIOUS SOFTWARE PROBLEM,¿ AND WAS UNABLE TO CLEAR THE ERROR OR PROCEED FURTHER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24850121 ↗
• 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 24842765 ↗
• 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 ↗

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