MyCareLink™ 24950KLQ (UDI 00643169725362)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00643169725362), received between Dec 7, 2017 and May 25, 2021 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (25 reports).

1 FDA recall record name this device's identifier.

9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jul 14, 2017Terminated

   Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports.

   Z-0399-2018 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2021Overheating of Device; Overheating of Device

  THE REMOTE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11876552 ↗
• MalfunctionMar 2, 2021Overheating of Device; Overheating of Device

  THE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11399509 ↗
• MalfunctionJun 18, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT TO THE TOUCH AND FELT AS IF IT WAS BURNING THE PATIENT. NO TROUBLESHOOTING WAS TAKEN. THE REMOTE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10166372 ↗
• MalfunctionMay 28, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT GOT SHOCKED BY THE READER WHEN TRYING TO SEND TRANSMISSIONS. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10096928 ↗
• MalfunctionApr 10, 2020Data Problem; Data Problem

  IT WAS REPORTED THAT THE CLINIC WAS GETTING INCORRECT READINGS FROM THE MONITOR. NO TROUBLESHOOTING INDICATED. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9947516 ↗
• MalfunctionAug 23, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR MALFUNCTIONED AND WAS SMOKING. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8926501 ↗
• MalfunctionJul 24, 2019Overheating of Device; Overheating of Device

  THE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8821312 ↗
• MalfunctionJul 17, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS SHOOTING OUT SPARKS. THE MONITOR WAS DAMAGED AS PER THE PATIENT AND NOT WILLING TO PLUG THE MONITOR BACK IN. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8799093 ↗
• MalfunctionJul 10, 2019Overheating of Device; Overheating of Device

  IT WAS FURTHER REPORTED THAT THE MONITOR HAS BEEN RETURNED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8775756 ↗
• MalfunctionJun 25, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS SMOKING AND ABOUT TO CATCH A FIRE. THE CALLER UNPLUGGED THE MONITOR FOR FEAR THAT IT WOULD BLOW UP. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8730910 ↗
• MalfunctionJun 20, 2019Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR HAD A STRONG BURNING ODOR AND WAS HOT. IT WAS ALSO REPORTED THAT A BROWN BURNT SPOT WAS NOTED UNDER THE REMOTE MONITOR. THE CALLER WAS INSTRUCTED TO IMMEDIATELY UNPLUG AND PLACE THE REMOTE MONITOR ON A NON-FLAMMABLE SURFACE. THE REMOTE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8716942 ↗
• MalfunctionMay 15, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. NO TROUBLESHOOTING TAKEN. THE REMOTE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8611372 ↗
• MalfunctionMay 3, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO THE TOUCH. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579343 ↗
• InjuryApr 12, 2019Therapeutic or Diagnostic Output Failure; Data Problem

  MY REVEAL LINQ LOOP RECORDER OR MEDTRONIC MYCARELINK PATIENT MONITOR WOULD NOT DOWNLOAD AND TRANSMIT DATA AT NIGHT TO BE SENT TO MY ELECTROPHYSIOLOGIST. IT WOULD ONLY TRANSMIT MANUALLY. MY PATIENT MONITOR NEEDED TO BE REPLACED TWICE. THE ISSUE IS THAT THIS IS THE 3RD MEDTRONIC MYCARELINK PATIENT MONITOR UNIT I'VE HAD TO BE SUPPLIED. THE PREVIOUS 2 FAILED OVERTIME TO TRANSMIT EVENTS AUTOMATICALLY, AS MEDTRONIC ADVERTISES. I'VE LOST MY CONFIDENCE THAT THESE UNITS ARE ABLE TO ACCURATELY RECORD AND TRANSMIT EVENTS WHICH WOULD GREATLY HELP IN ASSESSING MY HEALTH CONDITION AND GETTING IT RESOLVED. THE MOST RECENT EVENTS WHICH WERE NOT TRANSMITTED OR DOWNLOADED BY MEDTRONICS SYSTEMS, WAS A SEVERE EVENT FOR ME PERSONALLY, AND DR. (B)(6) (ELECTROPHYSIOLOGY) WAS JUST AS INCREDULOUS AS TO WHY THE DATA WAS NOT AVAILABLE TO HIM, EVEN THOUGH THE MEDTRONIC REP WHO WAS IN THE ROOM WITH US, HAD ACCESS TO THESE TRANSMISSIONS. IT IS ALSO QUESTIONABLE AS TO WHETHER INFORMATION WAS LOST DUE TO THE UNIT NOT TRANSMITTING ON A REGULAR BASIS AS MEDTRONIC STATES. THE LOCATION, SET UP, AND TIMING OF MY PATIENT MONITOR UNIT HAD NOT BEEN CHANGED AND NOR AM I MOVING AWAY FROM THE UNIT IN THE EVENING. SO WHY IS

  Patient problems: Failure of Implant

  MAUDE report 8515371 ↗
• MalfunctionJan 30, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE HANDSET OF THE REMOTE MONITOR WAS OVERHEATING. NO TROUBLESHOOTING TAKEN. THE REMOTE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8288558 ↗
• MalfunctionJan 28, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR SHOWS BATTERY RESIDUE. NO TROUBLESHOOTING TAKEN. THE MONITOR 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 8282876 ↗
• MalfunctionJan 18, 2019Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS RELEASING SOME WEIRD SMELL. IT WAS ALSO BELIEVED THAT THE REMOTE MONITOR TO BE ON FIRE AS IT STARTED TO SMOKE AND POWER CORD WAS EXTREMELY HOT. THE REMOTE MONITOR DID NOT GET WET AND WAS ON SOLID ITEM NOT ON FABRIC OR ANYTHING. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8262868 ↗
• MalfunctionJan 7, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE READER WAS TOO HOT TO TOUCH AND WAS "MORE THAN NORMAL". THE PATIENT WAS CONCERNED THAT THE READER WOULD BLOW UP ON THE PATIENT'S FACE. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8221182 ↗
• MalfunctionOct 11, 2018Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS EMITTING AN ELECTRICAL SMELL. NO TROUBLESHOOTING TAKEN. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7958254 ↗
• MalfunctionOct 1, 2018Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT SMELLED WHAT WAS BELIEVED TO BE A BURNING REMOTE MONITOR COMPONENT. THE PATIENT WAS ADVISED TO DISCONNECT THE REMOTE MONITOR AND WAIT FOR THE REPLACEMENT. THE REMOTE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7921468 ↗
• MalfunctionSep 28, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT. THE CALLER HAD UNPLUGGED THE REMOTE MONITOR FOR A WEEK. IT WAS EXPLAINED THAT THE REMOTE MONITOR MAY HEAT UP LIKE ANY OTHER ELECTRONIC DEVICE THAT IS PLUGGED IN AT ALL TIMES. THE REMOTE MONITOR COULD BE REPLACED BUT IT WAS NOT GUARANTEED THAT THE SAME ISSUE WOULD NEVER HAPPEN AGAIN. THE CALLER WAS ADVISED TO PLACE THE REMOTE MONITOR ON A FLAT, SOLID SURFACE AND NOT ON THE SHEETS. THE REMOTE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7917276 ↗
• MalfunctionAug 2, 2018Overheating of Device

  IT WAS REPORTED THAT WHEN SETTING UP THE INTERNET ACCESSORY AND SENDING A MANUAL TRANSMISSION, THE PATIENT STATED THAT THE REMOTE MONITOR WAS HOT, "IT HAS BEEN RUNNING HOT THAT YOU CAN BARELY PUT YOUR HAND ON IT." IT WAS LATER STATED THAT THE REMOTE MONITOR HAD COOLED OFF. THE REMOTE MONITOR 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 7741724 ↗
• MalfunctionJul 12, 2018Overheating of Device; Temperature Problem; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS "WARM". THE PATIENT STATED THAT MOST OF THE TIME, THE REMOTE MONITOR WAS JUST SLIGHTLY WARM BUT ALSO STATED THAT THE REMOTE MONITOR HAD BEEN "TOO HOT TO TOUCH". IT WAS OFFERED TO SEND A NEW REMOTE MONITOR AS IT SHOULD NOT GET "HOT". THE PATIENT OPTED TO CHECK FOR A FEW DAYS AND WOULD CALL BACK IF THE PATIENT WAS STILL CONCERNED. THE MONITOR 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 7681101 ↗
• MalfunctionJul 11, 2018Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS TOO HOT TO TOUCH. IT WAS EXPLAINED THAT ANY ELECTRONICS WHICH ARE CONNECTED ALL THE TIME WOULD BE WARM BUT SHOULD NOT BE TOO HOT TO TOUCH. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7677145 ↗
• MalfunctionJul 10, 2018Overheating of Device; Temperature Problem; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS BECOMING UNTOUCHABLY HOT. THE PATIENT INDICATED THAT THE HOUSE WAS STRUCK BY LIGHTNING ABOUT TWO MONTHS AGO. IT WAS STATED THAT THE REMOTE MONITOR WAS BEING UNPLUGGED EVERY TIME THE PATIENT WAS LEAVING THE HOUSE BECAUSE OF FEAR THAT THE REMOTE MONITOR WAS TOO HOT. THE CALLER WAS ADVISED TO UNPLUG THE REMOTE MONITOR COMPLETELY AND SET ASIDE. THE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7674995 ↗

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-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-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