CareLink SmartSync™ 24970A (UDI 00643169868540)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169868540), received between Aug 9, 2017 and Apr 10, 2018 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (6 reports).

10 other recalls cover devices cleared under the same FDA submission (K163008, 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2018Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER APPLICATION CRASHED DURING ATRIAL LEAD ANALYSIS. AN ALTERNATE ANALYZER WAS USED TO COMPLETE THE ANALYSIS. THE APPLICATION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7411852 ↗
• MalfunctionDec 10, 2017Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT UPON LEAD ANALYSIS, SENSING WAS ABLE TO BE CHECKED; HOWEVER, WHEN PROCEEDING TO VENTRICULAR PACING, THE APPLICATION CRASHED. FORCE CLOSING THE APPLICATION AND RESTARTING WAS REQUIRED TO COMPLETE THE CASE. THE MOBILE PROGRAMMER APPLICATION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103371 ↗
• MalfunctionDec 10, 2017Computer Software Problem; Device Displays Incorrect Message; Computer Software Problem; Device Displays Incorrect Message

  IT WAS REPORTED THAT UPON LEAD ANALYSIS, SENSING WAS ABLE TO BE CHECKED; HOWEVER, WHEN PROCEEDING TO PACING, THE APPLICATION CRASHED WITH AN ERROR MESSAGE. EXITING THE APPLICATION AND RELAUNCHING WAS REQUIRED. AFTER CONTINUING THROUGH THE RESET WINDOW, THE USER WAS ABLE TO COMPLETE THE LEAD ANALYSIS. THE MOBILE PROGRAMMER APPLICATION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103366 ↗
• MalfunctionDec 10, 2017Computer Software Problem; Device Displays Incorrect Message; Computer Software Problem; Device Displays Incorrect Message

  IT WAS REPORTED THE APPLICATION CRASHED MID-ATRIAL LEAD ANALYSIS. THE USER HAD TO EXIT THE APPLICATION AND RELAUNCH. IT WAS NECESSARY TO "PUSH" THROUGH THE SERIOUS ERROR SCREEN AND CONTINUE. BOTH LEADS WERE ABLE TO BE SUCCESSFULLY ANALYZED AFTER THE REBOOT. THE MOBILE PROGRAMMER APPLICATION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103359 ↗
• MalfunctionDec 10, 2017Device Displays Incorrect Message; Communication or Transmission Problem; Device Sensing Problem; Data Problem; Device Displays Incorrect Message; Communication or Transmission Problem; Device Sensing Problem; Data Problem

  IT WAS REPORTED THE USER COULD NOT ASSESS THE LEADS DURING THE CASE. UPON ATTEMPTING TO ANALYZE THE FIRST LEAD (ATRIAL), THE TABLET SHOWED DOTTED LINES ALL ALONG THE EGM (ELECTROGRAM) BASELINE. IT WAS FURTHER NOTED THERE WAS AN ERROR MESSAGE, AND QUESTION MARKS SHOWED IN MANY OF THE PARAMETER FIELDS. THE USER COULD NOT OPERATE THE APPLICATION AT THIS POINT, AND A FORCE CLOSE AND REBOOT OF THE APPLICATION APPEARED TO HAVE WORKED, BUT IT WAS TOO LATE INTO THE CASE TO DO THIS AND SUCCESSFULLY COMPLETE THE CASE, SO A LEGACY ANALYZER WAS USED TO COMPLETE THE CASE. THE MOBILE PROGRAMMER APPLICATION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7103356 ↗
• MalfunctionOct 10, 2017Device Difficult to Program or Calibrate; Device Displays Incorrect Message; Device Difficult to Program or Calibrate; Device Displays Incorrect Message

  IT WAS REPORTED THE TABLET SOFTWARE WOULD NOT ALLOW USER TO ADJUST PACING RATE OR MODE TO SET UP TEMPORARY PARAMETERS FOR LEAD ANALYSIS PRIOR TO LEAD CONNECTION. TROUBLESHOOTING WAS ATTEMPTED INCLUDING FORCE CLOSING THE APPLICATION AND RESETTING/UNPLUGGING THE BASE UNIT. IT WAS NOTED THE SCREEN HAD LOCKED UP AND HAD AN AUDIBLE CLICK WITHOUT RESPONDING, SO THE APPLICATION HAD TO BE FORCED CLOSED. A LOW BATTERY WARNING SCREEN ALSO DISPLAYED, WITH BRAND NEW BATTERIES, SO THE BATTERIES WERE REMOVED AND REINSTALLED, WITH NO SUCCESS. THE RATE OR MODE STILL COULD NOT BE ADJUSTED. THE SCREEN WOULD ONLY SHOW A VERY BRIEF HOURGLASS, AND THE FOLLOWING SCREEN WOULD NOT POPULATE AT ALL. ONLY ON PACING IN THE ATRIUM AND/OR THE VENTRICLE WAS ABLE TO BE TURNED ON, TO WHICH THEN THE ANALYZER WOULD NOMINALLY CHOOSE AAI, VVI, OR DDD MODES, AND IT WOULD PACE AT THE NOMINAL RATE OF 50 PPM (PACES PER MINUTE). AS A RESULT, THERE WAS NO WAY TO ANALYZE LEADS. THE MOBILE PROGRAMMER APPLICATION/ANDROID SET-UP WAS ABANDONED ALTOGETHER AND THE LEGACY PROGRAMMER/ANALYZER USED. IT WAS NOTED AGAIN THAT THE LOW BATTERY WARNING DISPLAYED, SO THE BATTERIES WERE REMOVED AND NEW BATTERIES REINSTALLED. THE ANALYZER WAS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6938488 ↗
• MalfunctionOct 10, 2017Device Difficult to Program or Calibrate; Device Displays Incorrect Message; Device Difficult to Program or Calibrate; Device Displays Incorrect Message

  IT WAS REPORTED THE TABLET SOFTWARE WOULD NOT ALLOW USER TO ADJUST PACING RATE OR MODE TO SET UP TEMPORARY PARAMETERS FOR LEAD ANALYSIS PRIOR TO LEAD CONNECTION. TROUBLESHOOTING WAS ATTEMPTED INCLUDING FORCE CLOSING THE APPLICATION AND RESETTING/UNPLUGGING THE BASE UNIT. IT WAS NOTED THE SCREEN HAD LOCKED UP AND HAD AN AUDIBLE CLICK WITHOUT RESPONDING, SO THE APPLICATION HAD TO BE FORCED CLOSED. A LOW BATTERY WARNING SCREEN ALSO DISPLAYED, WITH BRAND NEW BATTERIES, SO THE BATTERIES WERE REMOVED AND REINSTALLED, WITH NO SUCCESS. THE RATE OR MODE STILL COULD NOT BE ADJUSTED - THE SCREEN WOULD ONLY SHOW A VERY BRIEF HOURGLASS, AND THE FOLLOWING SCREEN WOULD NOT POPULATE AT ALL. ONLY ON PACING IN THE ATRIUM AND/OR THE VENTRICLE WAS ABLE TO BE TURNED ON, TO WHICH THEN THE ANALYZER WOULD NOMINALLY CHOOSE AAI, VVI, OR DDD MODES, AND IT WOULD PACE AT THE NOMINAL RATE OF 50 PPM (PACES PER MINUTE). AS A RESULT, THERE WAS NO WAY TO ANALYZE LEADS. THE MOBILE PROGRAMMER APPLICATION/ANDROID SET-UP WAS ABANDONED ALTOGETHER AND THE LEGACY PROGRAMMER/ANALYZER USED. IT WAS NOTED AGAIN THAT THE LOW BATTERY WARNING DISPLAYED, SO THE BATTERIES WERE REMOVED AND NEW BATTERIES REINSTALLED. THE ANALYZER WA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6938486 ↗
• MalfunctionOct 6, 2017Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE PROGRAMMER WAS FREEZING UP DURING USE. THE PROGRAMMER WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6920270 ↗
• MalfunctionAug 9, 2017Computer Software Problem; Power Problem; Computer Software Problem; Power Problem

  IT WAS REPORTED THERE WAS AN EXCESSIVE LAG IN TAP TO ACTION TIME WITH THE MOBILE PROGRAMMER APPLICATION AND SOME "CRASHES" WERE EXPERIENCED. ALSO, TWO NEW BATTERIES WERE INSTALLED, BUT A SERIOUS BATTERY ISSUE MESSAGE WAS RECEIVED WHICH PREVENTED THE ANALYZER FROM LAUNCHING. AFTER "KILLING" THE APPLICATION TWICE, DISCONNECTING THE TESTING CABLES, "KILLING" IT AGAIN AND RESTARTING, IT WORKED. HOWEVER, DURING TESTING LATER, IT CRASHED AGAIN AND CONTINUED TO GET A SERIOUS ERROR MESSAGE WITH AN ANALYZER ELECTRICAL RESET. IT WAS FURTHER NOTED THAT THERE WERE ISSUES WITH PRINTING. HITTING "RETURN" FROZE THE KEYBOARD AND PRESSING "VIEW" BEFORE SELECTING THE REPORT OPENED THE PREVIOUS REPORT. THE MOBILE PROGRAMMER APPLICATION WAS ABANDONED AND ANOTHER PROGRAMMER/ANALYZER MODEL WAS USED. THE MOBILE PROGRAMMER APPLICATION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6781105 ↗
• MalfunctionAug 9, 2017Device Displays Incorrect Message; Device Operational Issue; Device Displays Incorrect Message; Device Operational Issue

  IT WAS REPORTED AN ERROR MESSAGE APPEARED DURING IMPLANT INDICATING THE PROGRAMMED VALUE OR PROGRAMMED MODE COULD NOT BE ACCEPTED AND TO EXIT THE POP-UP BOX AND SELECT A NEW PARAMETER. THIS OCCURRED AFTER THE USER TRIED TO ASSESS LV (LEFT VENTRICULAR) LEAD PLACEMENT, WHILE TESTING LV TIP TO RING CONFIGURATION. AS A RESULT, A PACING MODE OR RATE TO ANALYZE THE LEAD COULD NOT BE SET. THE USER THEN EXITED THE POP-UP AND TRIED TO RE-SELECT, BUT THE SYSTEM LOCKED, WOULD NOT ALLOW THEM TO ADVANCE, AND WOULDN'T LAUNCH AFTER. THE APPLICATION WAS FORCED CLOSED, AND THE BASE STATION POWER WAS DISCONNECTED AND RECONNECTED, WHICH DID NOT WORK. FINALLY, A SOFT RESET OF THE TABLET WORKED. A DIFFERENT PROGRAMMER/ANALYZER MODEL WAS USED TO FINISH THE CASE. THE MOBILE PROGRAMMER APPLICATION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6780194 ↗
• MalfunctionAug 9, 2017Application Interface Becomes Non-Functional Or Program Exits Abnormally; Pacing Problem; Application Interface Becomes Non-Functional Or Program Exits Abnormally; Pacing Problem

  IT WAS REPORTED THAT DURING RIGHT VENTRICULAR (RV) LEAD TESTING FOR AN IMPLANTABLE PULSE GENERATOR (IPG) CHANGEOUT, ON A PATIENT WITH COMPLETE HEART BLOCK, THERE WAS A DELAY IN PACING. WHILE DOING SENSING MEASUREMENTS, AND INCREASING THE RATE TO 70 BEATS PER MINUTE (BPM), THERE WAS A DELAY (HOUR GLASS), THEN ONCE IT WENT TO 70 BPM, THERE WAS A DELAY (HOUR GLASS) BEFORE PACING RESUMED. THE PATIENT HAD A HEART RATE THAT CONSISTENTLY CAME IN AROUND 30 BPM. IN ADDITION, WHILE GENERATING REPORTS, THE ENTIRE APPLICATION LOCKED UP AND HAD TO BE SHUT DOWN TWICE. FOLLOWING THE SECOND TIME OF SHUTTING DOWN AND RE-BOOTING, THE KEYBOARD WOULD POP UP ON EVERY SCREEN INCLUDING THE THRESHOLD SCREEN AND BETWEEN THRESHOLD DECREMENTS. IT WAS UNUSABLE AND HAD TO BE RE-BOOTED AGAIN. AFTER THIS THIRD TIME, IT SEEMED TO WORK AT BASELINE LEVEL. THE MOBILE PROGRAMMER APPLICATION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6780181 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163008, 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-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