NA 24967 (UDI 00763000060428)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00763000060428), received between Apr 8, 2020 and Sep 11, 2026 — classified as 3 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (44 reports).

10 other recalls cover devices cleared under the same FDA submission (K163460, 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Display or Visual Feedback Problem; Communication or Transmission Problem; Problem with Software Installation

  It was reported that the blue portion of the patient connector used to hang around the patient's neck was damaged and required replacement. It was noted that the replacement connector displayed a security certificate expired message. It was further noted that the replacement connector could not be paired with the mobile programmer application due to Bluetooth connectivity issues. Troubleshooting steps were taken to include removing the Bluetooth pairing, rebooting the host tablet, and pairing the connector as a new device. It was further noted that a connector update needed message was displayed; however, the update failed despite multiple attempts. Performance data collected from the mobile programmer was received and analyzed. Analysis determined that Bluetooth connection was lost. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50732356 ↗
• MalfunctionAug 12, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219384 ↗
• MalfunctionMay 25, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT WHEN ATTEMPTING TO INTERROGATE THE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED), THE PATIENT CONNECTOR DISCONNECTED FROM THE HOST TABLETS BLUETOOTH AND WAS UNABLE TO RECONNECT. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE ENDING THE SESSION AND RECONNECTING THE PATIENT CONNECTOR WITH THE MOBILE PROGRAMMER APPLICATION WHICH RESOLVED THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25270017 ↗
• MalfunctionApr 24, 2026Communication or Transmission Problem; Inadequate User Interface

  IT WAS REPORTED THAT THE PATIENT CONNECTOR LOST TELEMETRY WITH THE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) AND THE CONNECTION COULD NOT BE RE-ESTABLISHED, DESPITE PLACING THE PATIENT CONNECTOR CLOSER TO THE IMPLANTABLE DEVICE AND TURNING OFF THE HOST TABLETS WIRELESS FIDELITY (WIFI). IT WAS NOTED THAT THE MOBILE PROGRAMMER APPLICATION INDICATED THE PATIENT CONNECTORS LOSS OF TELEMETRY BY THE RED INTERLOCK SYMBOL AND THAT QUESTION MARK SYMBOLS WERE DISPLAYED IN PLACE OF THE PROGRAMMED PARAMETERS. TROUBLESHOOTING STEPS WERE TAKEN TO END THE SESSION AND FORCE CLOSE AND RE-OPEN THE MOBILE PROGRAMMER APPLICATION TO FINALIZE PROGRAMMING WHICH RESOLVED THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 26.1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981709 ↗
• MalfunctionApr 20, 2026Communication or Transmission Problem; Inadequate User Interface

  APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 26.1

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24923708 ↗
• MalfunctionApr 15, 2026Communication or Transmission Problem; Output Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR LOST CONNECTION WITH THE MOBILE PROGRAMMER APPLICATION DURING AN INTERROGATION, AS REPRES ENTED BY A RED X IN THE CONNECTION STATUS INDICATOR AND THE LOSS OF ELECTROGRAMS (EGM). TROUBLESHOOTING STEPS WERE ADVISED TO INCLUDE RESETTING BLUETOOTH AND REBOOTING THE HOST TABLET WITH A VIEW TO RESOLVING THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 26.3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885810 ↗
• MalfunctionApr 10, 2026Communication or Transmission Problem

  T WAS REPORTED THAT THE PATIENT CONNECTOR HAD A REPEATED BLUETOOTH DISCONNECT WHEN ATTEMPTING TO INTERROGATE THE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED), AND WHEN IT WAS CONNECTED, THE IMPLANTABLE DEVICE WAS UNABLE TO BE LOCATED. TROUBLESHOOTING STEPS WERE TAKEN TO RESET THE BLUETOOTH CONNECTION ON THE HOST TABLET SETTINGS, FOLLOWED BY RE-PAIRING WITHIN THE MOBILE PROGRAMMER APPLICATION WHICH RESOLVED THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 26.2.1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843811 ↗
• MalfunctionMar 4, 2026Display or Visual Feedback Problem; Communication or Transmission Problem

  IT WAS FURTHER REPORTED APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 26.2.1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510957 ↗
• InjuryFeb 27, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR LOST CONNECTION TO THE MOBILE PROGRAMMER APPLICATION WHEN ATTEMPTING TO INTERROGATE AND PACE A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) DURING THE IMPLANT PROCEDURE. PATIENT¿S UNDERLYING HEART BLOCK WAS OBSERVED THAT RESULTED IN A PAUSE; HOWEVER, RECOVERED WITH AN ESCAPE RHYTHM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 26.1.

  Patient problems: Heart Block

  MAUDE report 24468825 ↗
• MalfunctionFeb 26, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR CONNECTED AND THEN DISCONNECTED WHEN ATTEMPTING TO PAIR TO THE MOBILE PROGRAMMER APPLICATION. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE FORGETTING THE CONNECTOR IN THE BLUETOOTH SETTINGS AND THEN UPDATING THE APPLICATION SOFTWARE VERSION WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. APPLICATION VERSION: 4.4.2 HOST TABLET OS VERSION: 18.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454035 ↗
• MalfunctionFeb 19, 2026Computer Software Problem

  IT WAS REPORTED THAT AFTER THE PATIENT CONNECTOR WAS CHANGED AND LEAD VERIFICATION TESTING WAS INITIATED, A WHITE SCREEN DISPLAYING AN UNEXPECTED ERROR MESSAGE APPEARED DURING ATRIAL THRESHOLD TESTING. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE CLOSING THE APPLICATION, RE-ASSOCIATING THE PATIENT CONNECTOR, AND RE-INTERROGATING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), AFTER WHICH TESTING WAS ABLE TO CONTINUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.5.2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386956 ↗
• MalfunctionJan 27, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR DISCONNECTED DURING INTERROGATION. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE SWAPPING OUT THE PATIENT CONNECTOR TO COMPLETE INTERROGATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188754 ↗
• MalfunctionJan 19, 2026Computer Software Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER APPLICATION LOST CONNECTION TO THE PATIENT CONNECTOR MIDWAY THROUGH AN INTERROGATION AND SUBSEQUENTLY CRASHED. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE RESTARTING THE APPLICATION AND RECONNECTING TO THE PATIENT CONNECTOR WHICH RESOLVED THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 26.1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108164 ↗
• MalfunctionNov 19, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE IMPLANTABLE PULSE GENERATOR (IPG) HAD BEEN PROGRAMMED AND PLACED INTO THE POCKET. WHEN TESTING WAS ATTEMPTED, THE PATIENT CONNECTOR LOST CONNECTION TO THE IPG AND ATTEMPTS TO RECONNECT WERE UNSUCCESSFUL. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE PLACING THE IPG IN DIRECT CONTACT WITH THE PATIENT CONNECTOR; HOWEVER, THE IPG STILL DID NOT RECONNECT. IT WAS NOTED THAT BATTERY LEVELS ON THE HOST TABLET, PATIENT CONNECTOR, AND IPG WERE CONFIRMED TO BE SUFFICIENT. THE IPG HAD INITIALLY BEEN SET ON A METAL TABLE PRIOR TO IMPLANTATION, BUT EVEN AFTER IMPLANTATION, CONNECTION COULD NOT BE REESTABLISHED FOR TESTING. THE IPG REMAINS IN USE. 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 23591537 ↗
• MalfunctionOct 29, 2025Computer Software Problem; Display or Visual Feedback Problem; Communication or Transmission Problem; Computer Operating System Problem; Output Problem; Computer Software Problem; Display or Visual Feedback Problem; Communication or Transmission Problem; Computer Operating System Problem; Output Problem

  APPLICATION VERSION: 4.4.2 HOST TABLET OS VERSION: 18.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413566 ↗
• MalfunctionOct 29, 2025Display or Visual Feedback Problem; Communication or Transmission Problem; Output Problem; Display or Visual Feedback Problem; Communication or Transmission Problem; Output Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION, WHEN THE PATIENT CONNECTOR WAS PLACED ON THE PATIENT¿S CHEST TO PERFORM DEVICE MEASUREMENTS, SENSING AND IMPEDANCE TESTING COMPLETED WITHOUT ISSUE. HOWEVER, DURING MANUAL THRESHOLD TESTING, THE PATIENT CONNECTOR REPEATEDLY DISCONNECTED FROM THE IMPLANTABLE DEVICE, PREVENTING THE TEST FROM BEING COMPLETED. IT WAS NOTED THAT THE ELECTROGRAMS (EGM) DISPLAY TURNED TO WHITE DOTS, ACCOMPANIED BY AN ERROR MESSAGE PROMPTING RECONNECTION TO THE IMPLANTABLE DEVICE. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE MINIMIZING THE MOBILE PROGRAMMER APPLICATION AND REOPENING IT TO FORCE RECONNECTION, WHICH WAS PERFORMED MULTIPLE TIMES DURING THE SESSION. 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 23413065 ↗
• MalfunctionOct 29, 2025Communication or Transmission Problem; Output Problem; Communication or Transmission Problem; Output Problem

  IT WAS REPORTED THAT DURING A IMPLANTATION, THE PATIENT CONNECTOR LOST CONNECTION TO THE MOBILE PROGRAMMER APPLICATION AND THE IMPLANTABLE DEVICE. IT WAS NOTED THAT THE TELEMETRY STRENGTH FLUCTUATED FROM THREE BARS TO ONE BAR, THEN LOST CONNECTION ENTIRELY WITHOUT ANY APPARENT MOVEMENT OR CHANGE. IT WAS FURTHER NOTED THAT THE ISSUE WAS PARTICULARLY EVIDENT DURING THRESHOLD TESTING WITH DROP BEFORE THE THRESHOLD TEST COULD BE COMPLETED AND THE ELECTROGRAMS (EGM) DISPLAY INTERMITTENTLY DROPPED OUT, SHOWING WHITE DOTS. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE SWAPPING OUT THE APPLICATION, HOWEVER CONNECTION CONTINUED TO DROP OUT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.4.2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412039 ↗
• MalfunctionAug 13, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR WAS UNABLE TO MAINTAIN CONNECTION TO THE MOBILE PROGRAMMER APPLICATION. NO PATIENT COMPLI CATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793647 ↗
• MalfunctionMay 8, 2025Communication or Transmission Problem; Unexpected Shutdown; Communication or Transmission Problem; Unexpected Shutdown

  IT WAS REPORTED THAT THE PATIENT CONNECTOR SUDDENLY LOST POWER. IT WAS NOTED THAT THE PATIENT CONNECTOR LOST COMMUNICATION WITH THE IMPLANTABLE DEVICE. IT WAS FURTHER NOTED THAT THE PATIENT CONNECTOR WAS UNABLE TO PAIR WITH THE HOST TABLET. THE PATIENT CONNECTOR HAS BEEN RETURNED FOR EVALUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21982533 ↗
• MalfunctionMay 8, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT AT THE END OF AN IMPLANT PROCEDURE WHILE MANUALLY CHECKING THE DEVICE CONNECTION WAS LOST BETWEEN THE PATIENT CONNECTOR, MOBILE APPLICATION AND IMPLANTABLE DEVICE. CONNECTION COULD NOT BE REESTABLISHED AND THE PATIENT CONNECTOR WAS CHANGED OUT FOR ANOTHER PATIENT CONNECTOR. THE PATIENT CONNECTOR HAS BEEN RETURNED FOR EVALUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21982399 ↗
• MalfunctionMay 2, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT AFTER DEVICE INTERROGATION AND SETTING MAGNETIC RESONANCE IMAGING (MRI) MODE, THE PATIENT CONNECTOR LOST COMMUNICATION WITH THE IMPLANTABLE DEVICE. AN ATTEMPT WAS MADE TO RE-ESTABLISH A CONNECTION INCLUDING ENDING SESSION AND RE-ATTEMPTING A CONNECTION BUT THIS WAS UNSUCCESSFUL. IT WAS REPORTED THAT THE PATIENT HAD A BOUT OF NAUSEA AND AS A RESULT THE MRI WAS CANCELLED. THE PATIENT CONNECTOR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949158 ↗
• MalfunctionMay 1, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT CONNECTOR BLUETOOTH CONNECTION FROZE UP ON INITIALIZATION. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE REBOOTING THE HOST TABLET AND HOLDING DOWN THE GREY BUTTON ON THE PATIENT CONNECTOR TO DISCONNECT HOWEVER THE ISSUE PERSISTED. TURNING OFF BLUETOOTH ENABLED THE PATIENT CONNECTOR TO BE DISCONNECTED. THE PATIENT CONNECTOR REMAINS IN USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940918 ↗
• MalfunctionMar 6, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS FURTHER REPORTED THE PATIENT CONNECTOR WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536066 ↗
• MalfunctionMar 3, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING THE FINAL TEST, THERE WAS A LOSS OF COMMUNICATION BETWEEN THE PATIENT CONNECTOR AND THE IMPLANTED DEVICE. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE ATTEMPTS TO RECONNECT; HOWEVER, CONNECTION WAS NOT RE-ESTABLISHED. THE PATIENT CONNECTOR REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503195 ↗
• InjuryJan 22, 2025Use of Device Problem; Communication or Transmission Problem; Use of Device Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), POST-TETHER REMOVAL, THRESHOLD WAS NOTED TO BE SLIGHTLY INCREASED. IT WAS NOTED THAT THE PATIENT CONNECTOR LOST TELEMETRY WITH THE IPG. POST-OPERATIVELY, THE PATIENT EXPERIENCED HEART RATE AT FIFTY BEATS PER MINUTE AND THE DEVICE WAS PACING BELOW THE PROGRAMMED LOWER RATE. THE DEVICE WAS REPROGRAMMED AND THE SENSITIVITY WAS CHANGED AND SHOWED SLIGHT IMPROVEMENT IN RIGHT VENTRICULAR (RV) THRESHOLD. PREMATURE VENTRICULAR CONTRACTIONS (PVC) WERE NOTED ON THE ELECTROGRAMS (EGM) AND THE RV SENSITIVITY WAS CHANGED AND SHORT V-V INTERVALS WERE ALSO OBSERVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206792 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163460, 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-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