CareLink SmartSync™ 24970A (UDI 00763000688400)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000688400), received between Nov 24, 2023 and Mar 3, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT DURING LEAD ADDITION, THE MOBILE PROGRAMMER BASE WAS UNABLE TO PAIR WITH THE MOBILE PROGRAMMER APPLICATION. IT WAS NOTED THAT THE PATIENT CONNECTOR CONNECTED; HOWEVER, THE BASE WOULD NOT DISPLAY A SERIAL NUMBER FOR PAIRING. ATTEMPTS TO RESET BLUETOOTH AND DISCONNECT/RECONNECT WERE UNSUCCESSFUL. NEITHER RAPID FLASHING NOR STEADY BLINKING OF THE BASE INITIATED A PAIRING SEQUENCE WITHIN THE APPLICATION. FORCE CLOSING AND RESTARTING THE APPLICATION, AS WELL AS POWERING OFF AND RESTARTING THE HOST TABLET, DID NOT RESOLVE THE ISSUE. DURING THIS TIME, THE PATIENT BECAME ASYSTOLIC AND WAS EXTERNALLY PACED VIA SURFACE PATCHES WHILE ATTEMPTS TO ESTABLISH ANALYZER FUNCTIONALITY CONTINUED. DUE TO THE INABILITY TO PAIR THE BASE, A LEGACY PROGRAMMER WAS OBTAINED TO QUICKLY ESTABLISH ANALYZER CAPABILITY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 26.2.

  Patient problems: Asystole

  MAUDE report 24496833 ↗
• MalfunctionNov 14, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT AN IMPLANTABLE DEVICE WAS SUCCESSFULLY INTERROGATED AT THE BEGINNING OF THE PROCEDURE. HOWEVER, AFTER THE IMPLANTABLE DEVICE WAS IMPLANTED, AN ATTEMPT WAS MADE TO RECONNECT FOR TESTING; HOWEVER, THE MOBILE PROGRAMMER APPLICATION SHOWED RED X¿S FOR BOTH THE MOBILE PROGRAMMER AND THE PATIENT CONNECTOR, AND CONNECTION COULD NOT BE ESTABLISHED. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE OBTAINING AN ADDITIONAL MOBILE PROGRAMMER APPLICATION SYSTEM, WHICH WAS THEN USED TO CHECK THE IMPLANTABLE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.2.3 HOST TABLET OS VERSION: 18.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553408 ↗
• MalfunctionOct 30, 2025Communication or Transmission Problem; Output Problem; Communication or Transmission Problem; Output Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER LOST CONNECTION TO THE IMPLANTABLE DEVICE AND THE ELECTROCARDIOGRAM (ECG) CHANNELS WENT BLANK DURING AN INTERROGATION SESSION. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE SWIPING OUT OF THE MOBILE PROGRAMMER APPLICATION AND REOPENING IT, BUT THE ISSUE PERSISTED. FURTHER TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE SWAPPING OUT THE MOBILE PROGRAMMER TO COMPLETE THE CASE. 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 23422404 ↗
• MalfunctionAug 25, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING LEFT VENTRICULAR (LV) LEAD TESTING WITH THE MOBILE PROGRAMMER, THE BLUETOOTH LIGHT INITIALLY INDICATED LOSS OF CONNECTION BY FLASHING, THEN RETURNED TO A SOLID BLUE LIGHT, BUT THE CONNECTION TO THE MOBILE PROGRAMMER WAS NOT REESTABLISHED AND CONTROL OF THE ANALYZER REMAINED LOST. IT WAS NOTED THAT PACING CONTINUED THROUGHOUT THE EVENT. MULTIPLE TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING PRESSING AND HOLDING THE BLUETOOTH BUTTON AND UNPLUGGING THE UNIT TO RESET IT; HOWEVER, THE CONNECTION DID NOT RETURN. A SECONDARY MOBILE PROGRAMMER APPLICATION SYSTEM WAS UTILIZED DUE TO THE LACK OF CONNECTION WITH THE INITIAL UNIT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882986 ↗
• MalfunctionJun 17, 2025Signal Artifact/Noise; Communication or Transmission Problem; Signal Artifact/Noise; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER EXPERIENCED A SENSING ISSUE WITH THE RIGHT ATRIAL (RA) LEAD, WHERE NOISE WAS OBSERVED DURING PASSIVE ANALYSIS, MAKING IT DIFFICULT TO ASSESS THE PASSIVE SENSING ON THE LEAD. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE SWAPPING OUT THE LEAD FOR A NEW LEAD, BUT THE SECOND LEAD RESULTED IN THE SAME WIDE BAND OF NOISE. IT WAS FURTHER REPORTED THAT THE ATTEMPTED AND SUCCESSFULLY IMPLANTED RIGHT ATRIAL (RA) LEADS EXHIBITED NOISE. ONE LEAD WAS ATTEMPTED NOT USED AND REPLACED WITH A SUCCESSFULLY IMPLANTED LEAD. PERFORMANCE DATA FROM THE MOBILE PROGRAMMER APPLICATION WAS RECEIVED AND IT WAS DETERMINED AT ANALYSIS THAT THE MOBILE PROGRAMMER APPLICATION HAD A LOSS OF CONNECTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22219592 ↗
• MalfunctionMar 7, 2025Communication or Transmission Problem; Computer Operating System Problem; Output Problem; Communication or Transmission Problem; Computer Operating System Problem; Output Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER CONTINUALLY LOST CONNECTION WITH THE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) AND THERE WAS NO COMMUNICATION OR INTERMITTENT COMMUNICATION WHERE "DOTS WERE PRESENT." IT WAS ALSO NOTED THAT THE MOBILE PROGRAMMER SCREEN WAS "LAGGY" WHILE THE ISSUE OCCURRED. THE MOBILE PROGRAMMER APPLICATION HOST TABLET HOME BUTTON WAS USED TO EXIT FROM THE APPLICATION AND IT WAS NOTED THAT THE APPLICATION WOULD FREEZE FOR SEVERAL SECONDS AND THEN RESUME COMMUNICATION WITHOUT THE DOTS, BUT THEN THE ISSUE WOULD REOCCUR AND THE APPLICATION PERFORMANCE WAS AGAIN SLUGGISH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547184 ↗
• MalfunctionNov 13, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), THE DEVICE EXHIBITED INTERMITTENT TELEMETRY. THE DEVICE WAS UNABLE TO BE INTERROGATED AND WAS UNABLE TO ESTABLISH TELEMETRY POSSIBLY DUE TO PATIENT'S CHEST ANATOMY BEING TOO THICK. THE DEVICE AND THE DELIVERY SYSTEM WAS ATTEMPTED, NOT USED AND WAS REPLACED. IT WAS NOTED THAT THE MOBILE PROGRAMMER HAD BEEN ABLE TO ESTABLISH TELEMETRY, INTERROGATE AND PROGRAMME THE IPG PRE-PROCEDURE HOWEVER WHEN THE IPG WAS IMPLANTED TELEMETRY WAS UNABLE TO BE ESTABLISHED DESPITE MULTIPLE ATTEMPTS FROM DIFFERENT POSITIONS. THE USER ENDED AND RESTARTED A SESSION TO RE-INTERROGATE AND DESPITE THE PATIENT CONNECTOR LIGHT DISPLAYING ORANGE THE IPG WAS UNABLE TO BE INTERROGATED IN THE PATIENT'S BODY. IT WAS NOTED THAT THE IPG WAS SUBSEQUENTLY ABLE TO BE INTERROGATED IN A BAG USING THE MOBILE PROGRAMMER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20671843 ↗
• MalfunctionSep 17, 2024Computer Software Problem; Computer Software Problem

  UPON ANALYSIS IT WAS DETERMINED THAT THE MOBILE PROGRAMMER CRASHED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20235016 ↗
• MalfunctionSep 4, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER LOST CONNECTION WITH THE MOBILE PROGRAMMER APPLICATION WHEN PERFORMING THRESHOLD TESTING DURING AN IMPLANT PROCEDURE. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE RESTARTING THE HOST TABLET AND RECONNECTING TO THE MOBILE PROGRAMMER AND PATIENT CONNECTOR, ALLOWING THE PROCEDURE TO CONTINUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20133619 ↗
• MalfunctionJul 24, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER GENERATED A MESSAGE ON THE MOBILE PROGRAMMER APPLICATION INDICATING THAT TELEMETRY WAS LOST. IT WAS NOTED THAT THE PATIENT CABLES HAD BEEN CONNECTED AND LEAD IMPEDANCE AND SENSING MEASUREMENTS WERE BEING CONDUCTED WHEN THE LOSS OF TELEMETRY OCCURRED. IT WAS FURTHER NOTED THAT CONNECTION WAS RESTORED AFTER A BRIEF PERIOD OF TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817015 ↗
• MalfunctionMar 25, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER DISPLAYED MORE NOISE IN THE ATRIAL CHANNEL IN COMPARISON TO THE VENTRICULAR CHANNEL. THE ANALYZER SURGICAL CABLES WERE SWAPPED OUT HOWEVER THE ISSUE PERSISTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966969 ↗
• MalfunctionNov 24, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE MOBILE PROGRAMMER APPLICATION LOST CONNECTION WITH THE PATIENT CONNECTOR WHILE PROGRAMMING THE IMPLANTABLE DEVICE PRIOR TO DEVICE HAND OFF FOR IMPLANTATION. THE USER RESTARTED THE SESSION IN ORDER TO RECONNECT THE PATIENT CONNECTOR. ONCE THE DEVICE WAS IN THE STERILE FIELD THE MOBILE PROGRAMMER APPLICATION LOST TELEMETRY WITH THE DEVICE. IT WAS ATTEMPTED TO END SESSION AND RECONNECT TO THE DEVICE WHICH DID NOT RESOLVE THE ISSUE. THE PATIENT CONNECTOR WAS THEN POSITIONED WITHIN THE STERILE FIELD IN ORDER TO MAKE PHYSICAL CONTACT WITH THE DEVICE WHICH ALSO WAS UNABLE TO RESOLVE THE ISSUE. THE MOBILE PROGRAMMER APPLICATION HOSTING DEVICE WAS THEN RESTARTED AND THE ISSUE WAS RESOLVED. IT WAS FURTHER REPORTED THAT THE MOBILE PROGRAMMER APPLICATION LOST CONNECTION TO THE PATIENT CONNECTOR AND MOBILE PROGRAMMER BASE DURING LEAD TESTING. THE SESSION WAS RESTARTED AND THE MOBILE PROGRAMMER APPLICATION RECONNECTED WITH THE PATIENT CONNECTOR AND MOBILE PROGRAMMER BASE. NO PATIENT COMPLICATIONS H AVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204163 ↗
• MalfunctionNov 24, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER APPLICATION LOST CONNECTION TO THE PATIENT CONNECTOR AND MOBILE PROGRAMMER BASE DURING AN INTERROGATION OF THE IMPLANTABLE DEVICE AND LEAD TESTING. THE SESSION WAS RESTARTED AND THE MOBILE PROGRAMMER APPLICATION RECONNECTED WITH THE PATIENT CONNECTOR AND MOBILE PROGRAMMER BASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18204100 ↗

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-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-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