NA 24967 (UDI 00763000688479)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00763000688479), received between Apr 30, 2024 and Sep 1, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (21 reports).

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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50541289 ↗
• MalfunctionAug 28, 2026Failure to Interrogate; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50493001 ↗
• MalfunctionAug 17, 2026Battery Problem; Communication or Transmission Problem; Problem with Software Installation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50273393 ↗
• MalfunctionApr 14, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT INTERROGATION COULD NOT BE PERFORMED AS THE PATIENT CONNECTOR REPEATEDLY DISCONNECTED FROM BLUETOOTH. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE RESETTING BLUETOOTH AND PERFORMING A HARD REBOOT WITH A VIEW TO RESOLVING THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.2.3 HOST TABLET OS VERSION: 18.1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24872785 ↗
• MalfunctionMar 25, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR WAS UNABLE TO MAINTAIN BLUETOOTH CONNECTION WITH THE MOBILE PROGRAMMER APPLICATION. TROUB LESHOOTING STEPS WERE TAKEN TO INCLUDE PERFORMING AN UPDATE OF THE APPLICATION SOFTWARE WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 18.6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24684772 ↗
• MalfunctionMar 19, 2026Communication or Transmission Problem

  APPLICATION VERSION: 4.4.2 HOST TABLET OS VERSION: 18.5

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637567 ↗
• MalfunctionJan 22, 2026Communication or Transmission Problem; Output Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER APPLICATION AND PATIENT CONNECTOR REPEATEDLY CYCLED BETWEEN CONNECTED AND DISCONNECTED STATES. IT WAS NOTED THAT AT THE START OF THE SESSION, ALL COMPONENTS CONNECTED SUCCESSFULLY; HOWEVER, ONCE THE SYSTEM ATTEMPTED TO CONNECT TO THE IMPLANTABLE DEVICE, INTERMITTENT CONNECTIVITY BEGAN, WITH WHITE DOTTED LINES VISIBLE ON THE ELECTROGRAMS (EGM) INDICATING UNSTABLE TELEMETRY. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE ENDING THE SESSION AND ATTEMPTING RECONNECTION; HOWEVER, THE ISSUE PERSISTED. ULTIMATELY, THE SESSION WAS ENDED, AND INTERROGATION WAS SUCCESSFULLY ACHIEVED ONLY AFTER SWITCHING TO A COMPLETELY DIFFERENT MOBILE PROGRAMMER APPLICATION AND PATIENT CONNECTOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.4.2 HOST TABLET OS VERSION: 18.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146132 ↗
• MalfunctionJan 7, 2026Communication or Transmission Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR WAS UNABLE TO PAIR TO THE MOBILE PROGRAMMER APPLICATION IN ORDER TO TAKE A PATIENT OUT OF MAGNETIC RESONANCE IMAGING (MRI) MODE. IT WAS NOTED THAT THAT THE SCREEN WAS FROZEN AND IT WAS NOT POSSIBLE TO TO FORCE CLOSE THE APPLICATION. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE ATTEMPTING TO SELECT A DIFFERENT PATIENT CONNECTOR; HOWEVER, THE PATIENT CONNECTOR DID NOT POPULATE ON THE SELECTION SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23989953 ↗
• MalfunctionDec 15, 2025Unexpected Shutdown; Unexpected Shutdown

  APPLICATION VERSION: 4.4.2 HOST TABLET OS VERSION: 18.6.2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804141 ↗
• MalfunctionNov 26, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE PATIENT CONNECTOR STOPPED WORKING DURING USE. AN ALTERNATIVE PROGRAMMER WAS USED TO CONTINUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655677 ↗
• MalfunctionAug 21, 2025Communication or Transmission Problem; Output Problem; Communication or Transmission Problem; Output Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR BRIEFLY LOST CONNECTION DURING AN IMPLANT WITH BOTH THE ELECTROCARDIOGRAM (ECG) AND ELECTROGRAMS (EGM) REPLACED BY DOTTED LINES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22858310 ↗
• MalfunctionJul 31, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR WAS UNABLE TO PAIR TO THE MOBILE PROGRAMMER APPLICATION. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE REMOVING THE CONNECTOR FROM BLUETOOTH AND PAIRED AGAIN; HOWEVER, CONNECTION WAS UNABLE TO BE MAINTAINED AND IT DISCONNECTED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674236 ↗
• MalfunctionJul 7, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR LOST TELEMETRY WITH THE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) AFTER ENABLING THE MAGNETIC RESONANCE IMAGING (MRI) SAFE MODE AND WAS UNABLE FOR THE TELEMETRY TO BE RE-ESTABLISHED TO DISABLE THE MODE. IT WAS NOTED THAT THE MOBILE PROGRAMMER APPLICATIONS SOFTWARE WAS TWO VERSIONS BEHIND THE CURRENT VERSION FOR BOTH THE OPERATING SYSTEM AND APPLICATION VERSIONS. ADDITIONALLY, IT WAS FURTHER NOTED THAT THE PATIENT CONNECTOR WAS OUT OF BATTERY AND UNABLE TO STAY POWERED ON WITHOUT BEING PLUGGED IN, AND THAT IT MAY HAVE RUN OUT OF BATTERY DURING THE SESSION, AS IT TYPICALLY REQUIRED TO HAVE AT LEAST 30% CHARGE TO FUNCTION PROPERLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412856 ↗
• MalfunctionJun 18, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR LOST BLUETOOTH CONNECTION WITH THE MOBILE PROGRAMMER APPLICATION DURING AN MAGNETIC RESONANCE IMAGING (MRI) SESSION. THE APPLICATION WAS RESTARTED AND THE USER WAS SUBSEQUENTLY ABLE TO RECONNECT TO THE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) AND DISABLE MRI MODE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284372 ↗
• MalfunctionJun 18, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR LOST CONNECTION WITH THE MOBILE PROGRAMMER APPLICATION DURING A MAGNETIC RESONANCE IMAGING (MRI) SESSION AND ATTEMPTS TO RE-PAIR RESULTED IN AN INTERMITTENT CONNECTION STATUS. THE USER RESET THE APPLICATION, APPLICATION HOSTING TABLET AND BLUETOOTH CONNECTION BUT WAS UNABLE 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 22283557 ↗
• MalfunctionJun 4, 2025Communication or Transmission Problem; Output Problem; Communication or Transmission Problem; Output Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER APPLICATION LOST TELEMETRY DISPLAYING A RED "X" BETWEEN THE APPLICATION AND PATIENT CONNECTOR AT THE TOP OF THE SCREEN, AND THE DOTS IN THE ELECTROCARDIOGRAM (ECG) DURING A SESSION. TROUBLESHOOTING STEPS WERE ADVISED TO INCLUDE SWAOOING OUT THE PATIENT CONNECTOR FOR THE NEXT PATIENT SESSION 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 22140080 ↗
• MalfunctionMay 1, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT PATIENT CONNECTOR LOST CONNECTIVITY WITH THE MOBILE HOSTING DEVICE DURING A DEFIBRILLATION THRESHOLD TESTING DEMONSTRATION. IT WAS ALSO NOTED THAT AFTER EXITING THE SESSION, AND RECONNECTING THE PATIENT CONNECTOR, AN UPDATE WAS PUSHED TO THE PATIENT CONNECTOR. THE PATIENT CONNECTOR REMAINS IN USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941208 ↗
• MalfunctionMar 31, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR AND THE HOST TABLET WERE UNABLE TO BE PAIRED. IT WAS FURTHER REPORTED THAT EVEN WHEN PAIRING WAS SUCCESSFUL, THE BLUETOOTH CONNECTION WAS LOST WHICH INHIBITED THE ABILITY TO INITIATE AN INTERROGATION SESSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729185 ↗
• MalfunctionMar 31, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR AND THE HOST TABLET WERE UNABLE TO BE PAIRED. IT WAS FURTHER REPORTED THAT EVEN WHEN PAIRING WAS SUCCESSFUL, THE BLUETOOTH CONNECTION WAS LOST WHICH INHIBITED THE ABILITY TO INITIATE AN INTERROGATION SESSION. TROUBLESHOOTING STEPS WERE ADVISED TO INCLUDE REPLACING THE PATIENT CONNECTOR WITH AN ALTERNATIVE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729184 ↗
• MalfunctionMar 11, 2025Computer Software Problem; Computer Operating System Problem; Computer Software Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER APPLICATION STOPPED WORKING DURING AN ACTIVE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) PROGRAMMING SESSION, THE USER WAS UNABLE TO END THE SESSION AND THE APPLICATION WAS UNRESPONSIVE TO TOUCH INPUT ON THE APPLICATION HOSTING TABLET TOUCH SCREEN. THE HOST TABLET WAS RESTARTED AND IT WAS THEN POSSIBLE TO END THE SESSION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21570537 ↗
• MalfunctionNov 1, 2024Display or Visual Feedback Problem; Communication or Transmission Problem; Display or Visual Feedback Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING IMPLANTABLE DEVICE REPLACEMENT PROCEDURE LOSS OF BLUE-TOOTH BETWEEN THE MOBILE PROGRAMMER PATIENT CONNECTOR AND THE IMPLANTABLE DEVICE WAS OBSERVED WITH A RED 'X' SYMBOL DISPLAYED. THE ISSUE WAS ENCOUNTERED WHEN THE NEW DEVICE AND LEADS WERE CONNECTED AS THE USER COMMENCED TESTING THE DEVICE THROUGH THE TESTING MENU. THE PATIENT CONNECTOR WAS THEN PLACED IN A STERILE COVER WHICH WAS THEN PLACED ON THE STERILE FIELD OVER THE DEVICE HOWEVER IT DID NOT CONNECT WITH THE NEW DEVICE AND DISPLAYED A DIAGNOSTIC MESSAGE STATING IT WAS UNABLE TO CONNECT AND DIRECTING THE USER TO TURN WIRELESS FIDELITY (WI-FI) OFF. THE WI-FI WAS TURNED OFF AND ON FOLLOWED BY FORCE CLOSING AND RE-STARTING THE MOBILE PROGRAMMER APPLICATION TO NO AVAIL. THE PATIENT CONNECTOR WAS THEN UNABLE TO BE PAIRED ALTHOUGH IT STILL HAD A SOLID BLUE LIGHT AND VARIOUS TROUBLESHOOTING STEPS ADVISED BY TECHNICAL SUPPORT FAILED TO RESOLVE THE ISSUE. A DIFFERENT PATIENT CONNECTOR WAS LOCATED TO COMPLETE THE PROCEDURE WHICH WAS SIGNIFICANTLY DELAYED. IT WAS NOTED THE CUSTOMER EXPRESSED DISSATISFACTION WITH THE PERFORMANCE OF THE PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585997 ↗
• MalfunctionOct 10, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR DISCONNECTED FROM THE MOBILE PROGRAMMER APPLICATION WITH THE BLUE LIGHT EMITTING DIODE (LED) TURNING OFF AND FAILING TO TURN BACK ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20417768 ↗
• MalfunctionAug 8, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR LOST TELEMETRY WHEN PERFORMING ELECTRICAL TESTING FOLLOWING IMPLANTATION OF THE CARDIOVAS CULAR IMPLANTABLE ELECTRONIC DEVICE (CIED). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937431 ↗
• MalfunctionApr 30, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR LOST CONNECTION WITH THE MOBILE PROGRAMMER APPLICATION MID-INTERROGATION. IT WAS NOTED THE PATIENT CONNECTOR WAS UNABLE TO RECONNECT. THE APPLICATION WAS RESTARTED AND THE ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211009 ↗

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-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