CareLink SmartSync™ 24970A (UDI 00763000201289)Recalls & reported problems

Summary

The FDA's MAUDE database contains 308 adverse event reports that list this exact device (DI 00763000201289), received between Jul 8, 2019 and Sep 28, 2026 — classified as 15 injuries, 293 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (126 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 308 reports, 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 ↗
• 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 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 ↗
• MalfunctionFeb 11, 2026Display or Visual Feedback Problem; Communication or Transmission Problem; Inadequate User Interface

  IT WAS FURTHER REPORTED THAT THE MOBILE PROGRAMMER WAS NOT READING THE CABLES DURING LEAD TESTING. ADDITIONAL TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE SWAPPING OUT THE APPLICATION WHICH FAILED TO RESOLVE THE ISSUE, RESULTING IN THE NECESSITY TO SWAP OUT THE MOBILE PROGRAMMER TO COMPLETE THE CASE. APPLICATION VERSION: 4.5.2 HOST TABLET OS VERSION: 26.2

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312531 ↗
• InjuryJan 14, 2026Display or Visual Feedback Problem; Pacing Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING RIGHT VENTRICULAR (RV) LEAD PLACEMENT, THE PATIENT LOST CONDUCTION AND EXPERIENCED ASYSTOLE. IT WAS NOTED THAT PACING USING THE MOBILE PROGRAMMER APPLICATION PACING SYSTEM ANALYZER (PSA) WAS ATTEMPTED AFTER RAPID LEAD FIXATION. PACING WAS INITIATED AT 90 BPM. APPROXIMATELY TWO MINUTES LATER, A REDUCTION IN PACING RATE TO 60 BPM WAS ATTEMPTED; HOWEVER, THE PSA DID NOT ACCEPT THE RATE CHANGE. IT WAS OBSERVED THAT THE DISPLAYED RATE CHANGED TO DISPLAY QUESTION MARK SYMBOLS AND A POP-UP MESSAGE APPEARED STATING THAT THE PARAMETER CHANGE WAS NOT CONFIRMED. MULTIPLE ATTEMPTS TO ADJUST THE PACING RATE WERE UNSUCCESSFUL, AND PACING CONTINUED AT 90 BPM. ATTEMPTS TO CHANGE THE PACING MODE FROM VVI TO VOO RESULTED IN THE SAME MESSAGE, WITH NO PARAMETER CHANGES APPLIED. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE CONFIRMING WIRELESS FIDELITY WAS TURNED OFF ON THE HOST TABLET AND VERIFYING THAT THE MOBILE PROGRAMMER AND PATIENT CONNECTOR WERE PAIRED. THE ISSUE PERSISTED DESPITE THESE ACTIONS. ADDITIONAL TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE SWAPPING THE MOBILE PROGRAMMER FOR A LEGACY PROGRAMMER WHICH WAS USED AS AN ALTERNATE PSA, ALLOWING THE MOBILE PROGRAMMER

  Patient problems: Asystole; Heart Block

  MAUDE report 24065053 ↗
• MalfunctionJan 13, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT DURING A IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANT USING THE MOBILE PROGRAMMER BASE, THERE WAS CONTINUOUS LOSS OF TELEMETRY AND REPEATED DISCONNECTIONS FROM THE IMPLANTED DEVICE THROUGHOUT THE PROCEDURE. TELEMETRY LOSS OCCURRED PRIOR TO THE DEVICE BEING PLACED ON THE STERILE FIELD AND CONTINUED INTERMITTENTLY WHILE CONNECTING TO THE ICD AND CHECKING MEASUREMENTS. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE REPOSITIONING THE BASE FROM THE PROGRAMMER CART TO THE PATIENT TABLE, THEN TO A TOWER POSITIONED ABOVE THE PATIENT, AS WELL AS MOVING THE PATIENT CONNECTOR CLOSER TO THE PATIENT¿S HEAD. IT WAS NOTED THAT WIFELESS FIDELITY WAS TURNED OFF DURING THESE ATTEMPTS. DESPITE THE TROUBLESHOOTING STEPS, TELEMETRY REMAINED INTERMITTENT, AND THE CONNECTION QUALITY WAS INSUFFICIENT TO SAFELY PROCEED WITH DEFIBRILLATION THRESHOLD (DFT) TESTING USING THE BASE. THEREFORE, THE SESSION WAS ENDED, AND THE PROCEDURE WAS COMPLETED USING A LEGACY PROGRAMMER. IT WAS THEN REPORTED THAT A BRIEF LOSS OF CONNECTION OCCURRED ONCE WITH THE LEGACY PROGRAMMER, BUT IT RECONNECTED IMMEDIATELY, AND NO FURTHER CONNECTION ISSUES WERE OBSERVED DURING DFT TESTING. NO PATIENT COMPLICATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051350 ↗
• MalfunctionDec 9, 2025Display or Visual Feedback Problem; Communication or Transmission Problem; Display or Visual Feedback Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER GENERATED A MESSAGE INDICATING THAT A LOSS OF BLUETOOTH HAD OCCURRED. NO PATIENT COMPLICA TIONS 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 23754873 ↗
• MalfunctionDec 9, 2025Display or Visual Feedback Problem; Communication or Transmission Problem; Display or Visual Feedback Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER GENERATED A MESSAGE INDICATING THAT A LOSS OF BLUETOOTH HAD OCCURRED. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE PERFORMING A HARD REBOOT OF THE HOST TABLET 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 23754489 ↗
• MalfunctionNov 14, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING PRE-PROCEDURE CASE SET UP, THE MOBILE PROGRAMMER DEMONSTRATED A LOSS OF BLUETOOTH CONNECTIVITY WITH PROGRAMMER BASE FOR APPROXIMATELY 20 SECONDS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553389 ↗
• MalfunctionNov 12, 2025Device Sensing Problem; Device Sensing Problem

  HOST TABLET OS VERSION:18.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530811 ↗
• MalfunctionOct 17, 2025Pacing Problem; Output Problem; Pacing Problem; Output Problem

  IT WAS REPORTED THAT DURING LEAD MEASUREMENTS, THE MOBILE PROGRAMMER INTERMITTENTLY STOPPED READING MEASUREMENTS FROM BOTH THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS. IT WAS NOTED THAT WHILE CHECKING THRESHOLDS, THE SIGNAL SWITCHED TO AN ISOELECTRIC LINE AND PACING STOPPED MOMENTARILY BEFORE RESUMING. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE REPLACING THE ANALYZER CABLES, REPLACING THE GRAY ADAPTERS THAT CONNECT THE PACING CABLES TO THE BASE, AND RESTARTING THE HOST TABLET; HOWEVER, THE ISSUE PERSISTED INTERMITTENTLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.2.3 HOST TABLET OS VERSION: 18.3.1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321041 ↗
• MalfunctionOct 17, 2025Pacing Problem; Output Problem; Pacing Problem; Output Problem

  IT WAS REPORTED THAT DURING LEAD MEASUREMENTS, THE MOBILE PROGRAMMER INTERMITTENTLY STOPPED READING MEASUREMENTS FROM BOTH THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS. IT WAS NOTED THAT WHILE CHECKING THRESHOLDS, THE SIGNAL SWITCHED TO AN ISOELECTRIC LINE AND PACING STOPPED MOMENTARILY BEFORE RESUMING. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE REPLACING THE ANALYZER CABLES, REPLACING THE GRAY ADAPTERS THAT CONNECT THE PACING CABLES TO THE BASE, AND RESTARTING THE HOST TABLET; HOWEVER, THE ISSUE PERSISTED INTERMITTENTLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.2.3 HOST TABLET OS VERSION: 18.3.1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321034 ↗
• MalfunctionOct 17, 2025Pacing Problem; Output Problem; Pacing Problem; Output Problem

  IT WAS REPORTED THAT DURING LEAD MEASUREMENTS, THE MOBILE PROGRAMMER INTERMITTENTLY STOPPED READING MEASUREMENTS FROM BOTH THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS. IT WAS NOTED THAT WHILE CHECKING THRESHOLDS, THE SIGNAL SWITCHED TO AN ISOELECTRIC LINE AND PACING STOPPED MOMENTARILY BEFORE RESUMING. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE REPLACING THE ANALYZER CABLES, REPLACING THE GRAY ADAPTERS THAT CONNECT THE PACING CABLES TO THE BASE, AND RESTARTING THE HOST TABLET; HOWEVER, THE ISSUE PERSISTED INTERMITTENTLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. APPLICATION VERSION: 4.2.3 HOST TABLET OS VERSION: 18.3.1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321031 ↗
• MalfunctionJul 30, 2025Computer Software Problem; Communication or Transmission Problem; Computer Operating System Problem; Computer Software Problem; Communication or Transmission Problem; Computer Operating System Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, AFTER CONNECTION OF LEADS, THE MOBILE PROGRAMMER FROZE WHEN ATTEMPTING THE IMPEDANCE CHECK. IT WAS NOTED THAT THE SCREEN WAS UNRESPONSIVE AND WHEN ATTEMPTING TO NAVIGATE AWAY AND BACK THE SCREEN WENT WHITE. IT WAS FURTHER NOTED THAT COMPLETE TELEMETRY WAS NOT MAINTAINED WITH THE IMPLANTABLE DEVICE THROUGHOUT THE SESSION. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE FORCE CLOSING AND RESTARTING THE APPLICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663225 ↗
• MalfunctionJul 30, 2025Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER CONTINUED TO FREEZE WHILE GENERATING A REPORT DESPITE MULTIPLE INTERROGATION ATTEMPTS. IT WAS ALSO NOTED THAT THE MOBILE PROGRAMMER APPLICATION PERFORMANCE WAS SLUGGISH. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE REBOOTING THE HOST TABLET, HOWEVER THE ISSUE PERSISTED AND THE APPLICATION WAS THEN SWAPPED OUT FOR A LEGACY PROGRAMMER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663108 ↗
• MalfunctionJul 9, 2025Communication or Transmission Problem; Output Problem; Communication or Transmission Problem; Output Problem

  IT WAS REPORTED THAT THE MOBILE PROGRAMMER LOST CONNECTION DURING A CASE DISPLAYING DOTS IN THE ELECTROGRAMS (EGM). 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 22457814 ↗

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-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