CareLink Encore™ 29901Recalls & reported problems

Summary

The FDA's MAUDE database contains 265 adverse event reports that list this exact device (DI 00643169369030), received between Dec 9, 2016 and May 6, 2026 — classified as 2 injuries, 263 malfunctions.

The most frequently reported specific device problem is “Computer Operating System Problem” (68 reports).

3 FDA recall records name this device's identifier, 1 still open.

9 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. 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 · Recall details · 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 · Recall details · FDA record ↗

3. Jan 17, 2019Terminated

   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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 265 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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; Communication or Transmission Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED AN ERROR MESSAGE INDICATING "SERIOUS SOFTWARE PROBLEM" UPON INTERROGATION OF AN IMPLAN TABLE DEVICE, AND IT FROZE FOR SOME TIME AND DISPLAYED A SYSTEM ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838194 ↗
• 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 24830777 ↗
• MalfunctionApr 9, 2026Computer Software Problem; Failure to Interrogate; Operating System Becomes Nonfunctional; Data Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PROGRAMMER FROZE AND DISPLAYED AN ERROR MESSAGE STATING, "DOWNLOADING INITIALIZING REPORTS, PLEASE WAIT," WHILE ON THE QUICK LOOK PAGE WHEN TRYING TO PRINT DOWNLOADS UPON INTERROGATING THE DEVICE. IT WAS ALSO NOTED THAT AFTER THREE MINUTES A BLACK AND WHITE SCREEN APPEARED AND THE PROGRAMMER DISPLAYED AN ERROR CODE INDICATING A ¿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 24825119 ↗
• MalfunctionMar 25, 2026Crack; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER SHUT DOWN ON ITS OWN, POSSIBLY DUE TO A COMPROMISED BATTERY. IT WAS NOTED THAT THE DISPLAY UNDERLAY WAS CRACKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687405 ↗
• MalfunctionJan 22, 2026Computer Operating System Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141786 ↗
• MalfunctionNov 11, 2025Computer Software Problem; No Display/Image; Overheating of Device; Computer Software Problem; No Display/Image; Overheating of Device

  IT WAS REPORTED THAT THE PROGRAMMER GENERATED AN ERROR MESSAGE INDICATING A SERIOUS PROGRAMMING ISSUE AND DISPLAYED A BLACK SCREEN. IT WAS NOTED THAT THE PROGRAMMER TENDS TO OVERHEAT AND WAS RUNNING ON BATTERY POWER AT THE TIME. THE BATTERY INDICATOR SHOWED THREE GREEN LIGHTS, INDICATING A FULL CHARGE. THE PROGRAMMER FUNCTIONED NORMALLY AFTER A REBOOT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520192 ↗
• InjuryMay 13, 2025Computer Software Problem; Computer Operating System Problem; Output Problem; Computer Software Problem; Computer Operating System Problem; Output Problem

  IT WAS REPORTED THAT THE PROGRAMMER FROZE DURING A RIGHT VENTRICULAR (RV) THRESHOLD TEST ON A PATIENT. THE THRESHOLD TEST WAS INITIATED BUT WOULD NOT CEASE AFTER CAPTURE WAS LOST. IT WAS NOTED THAT AFTER THE TEST BUTTON WAS RELEASED, THE AMPLITUDE CONTINUED TO DECREMENT, AND THE SCREEN OF THE ENCORE PROGRAMMER WAS FROZEN. THE PROGRAMMER REMAINED UNRESPONSIVE DESPITE MULTIPLE ATTEMPTS TO STOP THE THRESHOLD TEST, WHICH RESULTED IN ASYSTOLE AND SYNCOPE. IT WAS ALSO NOTED THAT THE PROGRAMMER DISPLAYED ERROR STATING SERIOUS PROGRAMMER PROBLEM. THE PROGRAMMER WAS THEN ABLE TO REBOOT AND OPEN TO THE NORMAL "FIND PATIENT" SCREEN. PATIENT WAS CONSCIOUS AGAIN WITHOUT ANY MEDICAL INTERVENTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole; Syncope/Fainting

  MAUDE report 22011768 ↗
• MalfunctionMay 2, 2025Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER¿S SCREEN WAS FROZEN DURING USE MULTIPLE TIMES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21948693 ↗
• MalfunctionApr 25, 2025Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER FROZE WHEN ATTEMPTING TO SELECT THE PRINT OPTION FOR PRINTING THE REPORTS FROM AN EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. IT WAS NOTED THAT THE ISSUE OCCURRED TWICE WITH THE SAME DEVICE AT THE SAME TIME. TROUBLESHOOTING STEPS WERE ADVISED TO INCLUDE PERFORMING A HARD REBOOT OF THE PROGRAMMER TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21906255 ↗
• MalfunctionMar 27, 2025Failure to Power Up; Unexpected Shutdown; Failure to Power Up; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER WAS UNABLE TO STAY POWERED ON EVEN WHEN PLUGGED INTO AN OUTLET. IT WAS NOTED THAT THE BATTERY WAS REPLACED, HOWEVER, THE PROGRAMMER THEN WAS UNABLE TO POWER ON. TROUBLESHOOTING STEPS WERE ADVISED TO REPLACE 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 21707166 ↗
• MalfunctionAug 22, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER POWERED OFF DURING A SESSION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039018 ↗
• MalfunctionJul 23, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER SPONTANEOUSLY SHUT DOWN DURING INTERROGATION OF AN IMPLANTABLE DEVICE. IT WAS NOTED THAT THE SHUTDOWN OCCURRED AFTER ADMINISTERING TESTING. TROUBLESHOOTING STEPS WERE ADVISED TO INCLUDE PERFORMING A HARD REBOOT OF THE PROGRAMMER AND REINTERROGATING WITH A VIEW TO RESOLVING THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805502 ↗
• MalfunctionJun 19, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PROGRAMMER BATTERY WAS UNABLE TO BE CHARGED. IT WAS NOTED THAT THAT WHEN THE PROGRAMMER WAS PLUGGED IN THE BATTERY LIFE FLASHED AND THERE WAS A LOSS OF CONNECTION. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE PERFORMING A HARD REBOOT OF THE PROGRAMMER AND CHECKING THE BATTERY LIFE, HOWEVER THE ISSUE PERSISTED. 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 19565734 ↗
• MalfunctionMay 15, 2024Connection Problem; Unexpected Shutdown; Connection Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER SHUT DOWN DURING USE AND THE POWER CORD WAS HELD IN POSITION WITH TAPE. IT WAS NOTED THAT THE RADIO FREQUENCY (RF) HEAD WAS FUNCTIONING POORLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19318403 ↗
• MalfunctionMay 7, 2024Computer Software Problem; Overheating of Device; Computer Software Problem; Overheating of Device

  IT WAS REPORTED THAT THE PROGRAMMER GENERATED A DIAGNOSTIC MESSAGE THAT INDICATED THAT THE PROGRAMMER WAS OVERHEATING. THE PROGRAMMER WAS REBOOTED AND THE DIAGNOSTIC MESSAGE DID NOT REAPPEAR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258048 ↗
• MalfunctionMar 27, 2024Display 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 FURTHER REPORTED THAT THE PROGRAMMER WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988147 ↗
• MalfunctionMar 26, 2024Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER SCREEN FROZE. THE PROGRAMMER RETURNED FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977085 ↗
• MalfunctionFeb 7, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE PROGRAMMER SCREEN WAS UNRESPONSIVE TO TOUCH. THE PROGRAMMER WAS RETURNED FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660590 ↗
• MalfunctionJan 5, 2024Computer Software Problem; Unexpected Shutdown; Computer Software Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE PROGRAMMER SPONTANEOUSLY POWERED DOWN DURING AN IMPLANTABLE DEVICE CHECK. IT WAS ALSO REPORTED THAT THE PROGRAMMER DISPLAYED A DIAGNOSTIC MESSAGE THAT INDICATED THE BATTERY HAD FAILED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18450686 ↗
• MalfunctionJan 3, 2024Display or Visual Feedback Problem; Computer Operating System Problem; Display or Visual Feedback Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER WAS INTERMITTENTLY UNABLE TO BOOT. THE PROGRAMMER HAS BEEN RETURNED FOR EVALUATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18433915 ↗
• MalfunctionNov 13, 2023Unexpected Shutdown; Unexpected Shutdown

  TROUBLESHOOTING STEPS OF USING DIFFERENT POWER CORDS AND POWER OUTLETS FAILED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18118188 ↗

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-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-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