CareLink SmartSyncRecalls & reported problems across all models

We found 4 models of CareLink SmartSync by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 513 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2017 and Sep 28, 2026 — classified as 24 injuries, 489 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (207 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CareLink SmartSync problems

CareLink SmartSync models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CareLink SmartSync™ 24970A

  TESTER, PACEMAKER ELECTRODE FUNCTION
  308 reports
• CareLink SmartSync™ 24970A

  TESTER, PACEMAKER ELECTRODE FUNCTION
  181 reports
• CareLink SmartSync™ 24970A

  TESTER, PACEMAKER ELECTRODE FUNCTION
  13 reports
• CareLink SmartSync™ 24970A

  ANALYZER, PACEMAKER GENERATOR FUNCTION
  11 reports

Recent CareLink SmartSync adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923837 ↗
• MalfunctionAug 24, 2026Computer Software Problem; Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50404906 ↗
• MalfunctionJul 28, 2026Failure to Power Up; Communication or Transmission Problem; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50063267 ↗
• MalfunctionJul 3, 2026Display or Visual Feedback Problem; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT A MESSAGE WAS DISPLAYED INDICATING THAT THE BATTERY WAS TOO LOW TO SAFELY INTERROGATE, WHEN ATTEMPTING TO LAUNCH THE MOBILE PROGRAMMER BASE ANALYZER FUNCTION. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE REPLACING THE BATTERIES IN THE BASE, LEAVING THE BATTERIES REMOVED FOR AT LEAST ONE MINUTE BEFORE INSTALLING NEW BATTERIES, RESTARTING THE MOBILE PROGRAMMER APPLICATION, AND RESTARTING THE HOST TABLET. IT WAS FURTHER NOTED THAT THE SAME ERROR MESSAGE WAS DISPLAYED FOLLOWING THE FIRST BATTERY REPLACEMENT. ADDITIONAL TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE REPLACING THE BATTERIES A SECOND TIME AND REATTEMPTING INTERROGATION. THE ISSUE PERSISTED FOLLOWING TROUBLESHOOTING, AND THE BASE REMAINED UNAVAILABLE FOR INTERROGATION. PERFORMANCE DATA FROM THE MOBILE PROGRAMMER WAS RECEIVED AND IT WAS DETERMINED AT ANALYSIS THAT THE MOBILE PROGRAMMER APPLICATION CRASHED. THERE WAS NO PATIENT INVOLVEMENT. APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 26.2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25701875 ↗
• MalfunctionJun 8, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER BASE LOST CONNECTION. IT WAS NOTED THAT THE WIRELESS FIDELITY (WIFI) WAS TURNED OFF. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE ENDING THE SESSION, REBOOTING THE HOST TABLET, FOLLOWED BY MANUALLY CONNECTING THE BASE IN THE BLUETOOTH SETTINGS IN AN ATTEMPT TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION:4.4.2 HOST TABLET OS VERSION: 18.6

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25426168 ↗
• 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 ↗
• MalfunctionMay 11, 2026Communication or Transmission Problem; Problem with Software Installation

  IT WAS REPORTED THAT THE PATIENT CONNECTOR AND MOBILE PROGRAMMER BASE FAILED TO UPDATE. THE PATIENT CONNECTOR WAS PAIRED TO A DIFFERENT HOST TABLET AND WAS THEN ABLE TO CERTIFICATE SUCCESSFULLY, HOWEVER THE BASE CONTINUED TO FAIL. CERTIFICATE UPDATE INSTRUCTION WERE PROVIDED BY TECHNICAL SUPPORT AND IT WAS ADVISED TO RETURN THE BASE AND OBTAIN A NEW INSTRUMENT. PERFORMANCE DATA FROM THE MOBILE PROGRAMMER WAS RECEIVED AND IT WAS DETERMINED AT ANALYSIS THAT THE MOBILE PROGRAMMER BASE HAD A DISCONNECTION DURING THE UPDATE. THERE WAS NO PATIENT INVOLVEMENT. APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 26.1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136557 ↗
• MalfunctionApr 28, 2026Under-Sensing; Output Problem

  IT WAS REPORTED THAT WHILST USING THE MOBILE PROGRAMMER PACING SYSTEM ANALYZER (PSA) ON A PATIENT IN FINE ATRIAL FIBRILLATION, EXCESSIVE ATRIAL CHANNEL NOISE WAS PRESENT LEADING TO UNDER-SENSING OCCURRING. IT WAS NOTED THAT WIRELESS FIDELITY (WIFI) HAD BEEN TURNED OFF ON THE HOST TABLET AND THE MOBILE PROGRAMMER BASE HAD BEEN PLUGGED DIRECTLY INTO THE POWER OUTLET IN ADDITION TO THE HOST TABLET BEING SEPARATED FROM THE MOBILE PROGRAMMER BASE. IT WAS FURTHER NOTED THAT THE CORRECT CABLES WERE BEING USED. TROUBLESHOOTING STEPS WERE TAKEN TO SWAP OUT THE MOBILE PROGRAMMER BASE FOR AN ALTERNATIVE PROGRAMMER WHICH WAS ABLE TO PICK UP THE FINE ATRIAL FIBRILLATION WAVES RANGING BETWEEN 0.6 AND 1.0 MILLIVOLTS (MV) WHICH RESOLVED THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 3.11.6 HOST TABLET OS VERSION: 26.3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25012555 ↗
• MalfunctionApr 27, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INTERMITTENT CAPTURE. THE LEAD EXHIBITED A MICRO DISLODGEMENT POST POC KET CLOSURE. IT WAS FURTHER REPORTED THAT MOBILE PROGRAMMER ANALYZER LOST CONNECTION TO THE MOBILE PROGRAMMER APPLICATION FOR A BRIEF PERIOD, AS REPRESENTED BY A RED X IN THE CONNECTION STATUS INDICATOR. IT WAS ALSO NOTED THAT THE MOBILE PROGRAMMER WAS UNABLE TO P AIR TO THE APPLICATION. THE LEAD WAS EXPLANTED AND REPLACED. 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 24994963 ↗
• MalfunctionApr 23, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WERE PAIRING ISSUES BETWEEN THE MOBILE PROGRAMMER BASE AND THE MOBILE PROGRAMMER APPLICATION. IT WAS NOTED THAT WHEN PAIRING WAS ACHIEVED, CONNECTION WAS INTERMITTENTLY LOST AND CAPTURE WAS NOT DISPLAYED ACCURATELY OR DISPLAY OF CAPTURE WAS DELAYED. AFTER PAIRING, THE ANALYZER WAS LAUNCHED AND A POP-UP MESSAGE APPEARED STATING, ¿UNABLE TO RETRIEVE DATA. NO CONNECTION TO BASE,¿ DESPITE THE BASE REMAINING SHOWN AS PAIRED WITHIN THE APPLICATION. IT WAS FURTHER REPORTED THAT THE MOBILE PROGRAMMER WAS NOT READING THE CABLES DURING LEAD TESTING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 26.2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968692 ↗
• MalfunctionApr 22, 2026Device Sensing Problem; Output Problem

  IT WAS REPORTED THAT ATRIAL OVERSENSING WAS OBSERVED ON THE MOBILE PROGRAMMER DURING AN IMPLANT. IT WAS NOTED THAT THE ATRIAL ELECTROGRAMS (EGM) DISPLAYED A CONSTANT ARTIFACT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24949716 ↗
• MalfunctionApr 8, 2026Communication or Transmission Problem; Output Problem

  HOST TABLET OS VERSION: 26.3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24813370 ↗
• 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 ↗
• MalfunctionMar 10, 2026Computer Software Problem; Display or Visual Feedback Problem; Problem with Software Installation

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A NEW MOBILE PROGRAMMER APPLICATION, AN ATTEMPT WAS MADE TO UPDATE THE MOBILE PROGRAMMER BASE AFTER A MESSAGE WAS GENERATED INDICATED THAT AN UPDATE WAS AVAILABLE; HOWEVER, THE MOBILE PROGRAMMER APPLICATION REPEATEDLY EXITED WHEN THE UPDATE WAS ATTEMPTED. REBOOT ATTEMPTS WERE PERFORMED MULTIPLE TIMES AND THE BEHAVIOR PERSISTED. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE REBOOTING THE BASE, REMOVING THE BASE FROM BLUETOOTH SETTINGS, FORCE CLOSING ALL APPLICATIONS ON THE HOST TABLET, AND PAIRING THE BASE AGAIN THROUGH BLUETOOTH. ANOTHER UPDATE ATTEMPT WAS PERFORMED AND IT FAILED, A RETRY WAS SELECTED, AND THE UPDATE FAILED AGAIN. THERE WAS NO PATIENT INVOLVEMENT. APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 26.2.1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556581 ↗

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