CareLink SmartSync™ 24970A (UDI 00643169957657)Recalls & reported problems

Summary

The FDA's MAUDE database contains 181 adverse event reports that list this exact device (DI 00643169957657), received between Apr 24, 2019 and Jun 4, 2026 — classified as 8 injuries, 173 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (69 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 25 most recent of 181 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER LOST TELEMETRY WITH THE MOBILE PROGRAMMER APPLICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 18.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25391058 ↗
• MalfunctionJun 4, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER LOST TELEMETRY WITH THE MOBILE PROGRAMMER APPLICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 18.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25391019 ↗
• MalfunctionMar 12, 2026Problem with Software Installation

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER WAS UNABLE TO UPDATE ITS FIRMWARE. THE MOBILE PROGRAMMER WAS RETURNED FOR EVALUATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT. APPLICATION VERSION: 4.4.2 HOST TABLET OS VERSION: 18.3.1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582511 ↗
• MalfunctionJan 20, 2026Communication or Transmission Problem; Output Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER DISCONNECTED FROM THE MOBILE PROGRAMMER APPLICATION DURING AN ANALYZER SESSION, DISPLAYING A DOTTED LINE ON THE SCREEN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.4.2 HOST TABLET OS VERSION: 18.6.2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24113573 ↗
• MalfunctionDec 4, 2025Display or Visual Feedback Problem; Communication or Transmission Problem; Problem with Software Installation; Display or Visual Feedback Problem; Communication or Transmission Problem; Problem with Software Installation

  IT WAS REPORTED THAT DURING A NEW SETUP OF THE MOBILE PROGRAMMER APPLICATION, THE MOBILE PROGRAMMER BASE GENERATED A MESSAGE INDICATING THAT IT FAILED TO COMPLETE AND TO RETRY WHEN PAIRING WAS ATTEMPTED. IT WAS NOTED THAT WHEN THE BASE SERIAL NUMBER WAS ENTERED, AN INCOMPATIBLE BASE MESSAGE APPEARED. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE REMOVING THE BATTERIES FOR AT LEAST ONE MINUTE BEFORE REINSTALLING THEM, FORCE CLOSING ALL APPLICATIONS ON THE HOST TABLET, AND REBOOTING THE BASE. THE BASE WAS THEN ATTEMPTED TO BE UPDATED AGAIN THROUGH THE APPLICATION SETUP. THE BASE CONNECTED BRIEFLY BUT DISCONNECTED ON ITS OWN, AND ITS INDICATOR LIGHT FLASHED RAPIDLY. PAIRING WAS ATTEMPTED THROUGH THE HOST TABLET¿S BLUETOOTH SETTINGS, BUT A CONNECTION UNSUCCESSFUL MESSAGE APPEARED. AFTER FORGETTING AND REPAIRING THE DEVICE IN BLUETOOTH, THE BASE SUCCESSFULLY PAIRED; HOWEVER, THE UPDATE CONTINUED TO FAIL MULTIPLE TIMES WHEN RETRY WAS SELECTED WITHIN THE MOBILE PROGRAMMER APPLICATION. THERE WAS NO PATIENT INVOLVEMENT. APPLICATION VERSION: 4.4.2 HOST TABLET OS VERSION: 18.6.2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715951 ↗
• MalfunctionMar 18, 2025Computer Software Problem; Display or Visual Feedback Problem; Computer Software Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER DISPLAYED A WHITE SCREEN WITH A DIAGNOSTIC MESSAGE INDICATING THAT AN UNEXPECTED ERROR HAD OCCURRED DURING A PROCEDURE WHEN THE USER WAS TRANSFERRING DATA FROM THE ANALYZER TO THE DEVICE. IT WAS NOTED THAT THE MOBILE PROGRAMMER WAS CLOSED AND RE-OPENED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. THE MOBILE PROGRAMMER 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 21629949 ↗
• MalfunctionFeb 25, 2025Computer Software Problem; Display or Visual Feedback Problem; Computer Software Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER DISPLAYED A MESSAGE INDICATING THAT THE SOFTWARE HAD BEEN UPDATED AND THEN THE MOBILE PRO GRAMMER CRASHED. THE USER THEN INTERROGATED A DEVICE DURING A DEMONSTRATION AND THE MOBILE PROGRAMMER INDICATED THE DEVICE SOFTWARE HAD BEEN UPDATED AND THEN AN UNEXPECTED ERROR WAS DISPLAYED. TROUBLESHOOTING STEPS WERE TAKEN WHICH INVOLVED UNINSTALLING AN REINS TALLING THE MOBILE PROGRAMMER APPLICATION HOWEVER THE ISSUE PERSISTED. FURTHER TROUBLESHOOTING ADVICE WAS PROVIDED. THE MOBILE PROGRAMMER REMAINS IN USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458418 ↗
• MalfunctionFeb 12, 2025Signal Artifact/Noise; Wireless Communication Problem; Signal Artifact/Noise; Wireless Communication Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER DISPLAYED NOISE ON THE ATRIAL LEAD. TROUBLESHOOTING STEPS WERE ADVISED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. UPON ANALYSIS IT WAS NOTED THAT THERE WAS A LOSS OF TELEMETRY CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362255 ↗
• MalfunctionJan 30, 2025Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER FROZE WHEN IN THE ANALYZER SCREEN WHILE TESTING THE RIGHT VENTRICULAR (RV) LEAD. THE MOBILE PROGRAMMER APPLICATION WAS CLOSED AND RESTARTED BY THE USER AND FROZE AGAIN WHEN ATTEMPTING TO GO FROM THE ANALYZER TO THE ACTIVE IMPLANTABLE DEVICE. THE MOBILE PROGRAMMER WAS SWAPPED OUT FOR ANOTHER MOBILE PROGRAMMER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21271876 ↗
• MalfunctionJan 7, 2025Failure to Capture; Pacing Problem; Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER WAS PACING THE INCORRECT RATE. IT WAS ALSO NOTED THAT THE PACING WAS NOT BEING CAPTURED.  TROUBLESHOOTING STEPS WERE ADVISED TO INCLUDE UPDATING BOTH THE HOST TABLET AND MOBILE PROGRAMMER APPLICATION AS A SAFETY PRECAUTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21090629 ↗
• MalfunctionNov 29, 2024Communication or Transmission Problem; Computer Operating System Problem; Communication or Transmission Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER DISCONNECTED FROM THE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) DURING RIGHT VE NTRICULAR (RV) THRESHOLD TESTING DURING AN IMPLANT AND BECAME UNRESPONSIVE. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE CLOSING AND RESTARTING THE MOBILE PROGRAMMER APPLICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20810598 ↗
• MalfunctionNov 11, 2024Computer Software Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Computer Software Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER GENERATED A DIAGNOSTIC MESSAGE INDICATING THAT THE PARAMETER CHANGE WAS NOT CONFIRMED AND DISPLAYED QUESTION MARK SYMBOLS IN THE MODE AFTER GOING OFF AND COMING BACK ONTO A THRESHOLD. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE CLOSING OUT AND RELAUNCHING THE MOBILE PROGRAMMER APPLICATION, HOWEVER A WHITE SCREEN WAS DISPLAYED WITH A DIAGNOSTIC MESSAGE INDICATING THAT AN UNEXPECTED ERROR HAD OCCURRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650146 ↗
• MalfunctionSep 17, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER LOST CONNECTION AT THE END OF A CASE. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE ENDING THE SESSION AND RECONNECTING 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 20234755 ↗
• MalfunctionSep 17, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER PLUG CAME LOOSE RESULTING IN A LOSS OF COMMUNICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20234747 ↗
• MalfunctionSep 17, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER LOST CONNECTION PRIOR TO A CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20234745 ↗
• MalfunctionJun 7, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT PROCEDURE THERE WERE AT LEAST TEN INSTANCES OF THE MOBILE PROGRAMMER PATIENT CONNECTOR LOSING CONNECTION WITH THE MOBILE PROGRAMMER BASE. IT WAS NOTED THAT THE PATIENT CONNECTOR MAINTAINED CONNECTION WITH THE IPG AND THE ISSUE OCCURRED WHEN IT WAS ATTEMPTED TO PERFORM MANUAL SENSING, IMPEDANCE AND THRESHOLD TESTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483020 ↗
• MalfunctionMar 22, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER APPLICATION CRASHED TO A WHITE SCREEN WHEN NAVIGATING THROUGH THE PARAMETERS SCREEN. THE APPLICATION WAS RESTARTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958075 ↗
• MalfunctionFeb 1, 2024Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER SCREEN DISPLAYED AN HOURGLASS SYMBOL WHICH PERSISTED FOR FIVE MINUTES UPON INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRIOR TO REPLACEMENT PROCEDURE. IT WAS NOTED THAT THE DATA SUMMARY SCREEN AND RHYTHM WAS VISIBLE HOWEVER THE ISSUE PREVENTED THE USER FROM NAVIGATING THROUGH THE ICD APPLICATION SCREEN. THE USER THEN FORCE-CLOSED THE MOBILE PROGRAMMER APPLICATION AND USED A LEGACY PROGRAMMER TO INTERROGATE THE ICD WHICH WAS SUCCESSFUL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18622280 ↗
• MalfunctionMay 23, 2023Computer Software Problem; Power Problem; Computer Software Problem; Power Problem

  IT WAS REPORTED THAT, WHILE TESTING VENTRICULAR THRESHOLDS, THE TABLET HOSTING THE PROGRAMMER APPLICATION RESTARTED. IT WAS NOTED THAT THE ANALYZER CONTINUED TO PACE THE PATIENT UNTIL DEVICE WAS CONNECTED TO LEADS. ONCE THE TABLET STARTED, APPLICATION WAS RELAUNCHED, AND LEAD TESTING AND PROGRAMMING WAS COMPLETED WITHOUT ISSUE. THE PROGRAMMER WAS 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 16983688 ↗
• MalfunctionApr 28, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT COMMUNICATION WAS LOST WITH THE MOBILE PROGRAMMER BASE DURING LEAD TESTING THROUGH THE ANALYZER. IT WAS NOTED THAT THE MOBILE PROGRAMMER WAS RESTARTED TO RESOLVE THE ISSUE. THE MOBILE PROGRAMMER 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 16832178 ↗
• MalfunctionApr 28, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT COMMUNICATION WAS LOST WITH THE MOBILE PROGRAMMER BASE DURING LEAD TESTING THROUGH THE ANALYZER. IT WAS NOTED THAT THE MOBILE PROGRAMMER WAS RESTARTED TO RESOLVE THE ISSUE. THE MOBILE PROGRAMMER 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 16831761 ↗
• MalfunctionApr 28, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT AT A CRITICAL POINT WHILE THRESHOLD TESTING WITH THE MOBILE PROGRAMMER, THE CONNECTION BETWEEN THE BASE AND TABLET WAS LOST . NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831596 ↗
• MalfunctionApr 28, 2023Display or Visual Feedback Problem; Communication or Transmission Problem; Display or Visual Feedback Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER LOST COMMUNICATION THREE TIMES RESULTING IN A RED "X" BEING DISPLAYED BETWEEN THE BASE AND THE TABLET ICONS. IT WAS NOTED THAT THE APPLICATION WAS RELAUNCHED AND THE BASE AND TABLET WERE RECONNECTED. AFTER THE FIRST LOSS OF COMMUNICATION THE WIRELESS FIDELITY (WIFI) WAS ACCESSED AND TURNED OFF. ALL OTHER APPLICATIONS WERE TURNED OFF ALSO. IT WAS NOTED THAT FIRST LOSS OF COMMUNICATION OCCURRED PRIOR TO THE PROCEDURE. IT WAS NOTED THAT IN THE FOLLOWING TWO OCCURRENCES THE BASE AND TABLET WENT FROM COMMUNICATING NORMALLY TO NO COMMUNICATION. IT WAS FURTHER NOTED THAT IN ALL THREE INSTANCES THE MOBILE PROGRAMMER BASE WAS PAIRED WITH THE TABLET AND THE ANALYZER APPLICATION WAS RUNNING WITH THE TABLET SITTING DIRECTLY ON TOP OF THE BASE. LATER IN THE PROCEDURE THE ANALYZER WAS CHANGED OUT FOR ANOTHER PROGRAMMER MODEL LATER AND THE DEVICE SESSION VIA THE PATIENT CONNECTOR WAS DONE USING THE SAME TABLET WITH NO ISSUES EXPERIENCED BETWEEN THE TABLET AND PATIENT CONNECTOR. IT WAS NOTED THAT IT WAS A VERY LENGTHY CASE AND THE USER ESTIMATED THAT THE THREE INSTANCES OF LOSS OF COMMUNICATION OCCURRED WITHIN THE FIRST HOUR OF THE CASE, AND AFTER THE THI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831457 ↗
• MalfunctionFeb 14, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER LOST CONNECTION DURING LEAD ANALYSIS. IT WAS NOTED THAT THE MOBILE PROGRAMMER APPLICATION WAS UNABLE TO REESTABLISH CONNECTION. THE PROCEDURE WAS COMPLETED USING A LEGACY PROGRAMMER. THE MOBILE PROGRAMMER 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 16370419 ↗
• InjuryJan 3, 2023Display or Visual Feedback Problem; Pacing Problem; Communication or Transmission Problem; Computer Operating System Problem; Display or Visual Feedback Problem; Pacing Problem; Communication or Transmission Problem; Computer Operating System Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE MOBILE PROGRAMMER ANALYZER AND HOST TABLET COMMUNICATION DROPPED AND FAILED TO PACE WHEN CABLES WERE CONNECTED, EMERGENCY PACING WAS ALSO UNABLE TO BE PERFORMED. THE NEW PACEMAKER WAS CONNECTED TO PROVIDE PROVIDE PACING. IT WAS FURTHER REPORTED THAT THE RESPONSE FROM THE MOBILE PROGRAMMER WAS SLOW AND SEVERAL QUESTION MARKS WERE DISPLAYED IN THE PACING MODE SELECTIONS. THE MOBILE PROGRAMMER 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 16085088 ↗

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-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