MyCareLink™ 24950JLQ (UDI 00643169705753)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169705753), received between Dec 9, 2016 and Dec 28, 2020 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (14 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 18, 2026.

Recalls naming this device

1. Jul 14, 2017Class IITerminated

   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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR READER WAS TOO HOT TO TOUCH WHEN IT WAS PICKED UP. THE PATIENT WAS ADVISED TO UNPLUG AND SET ASIDE THE REMOTE MONITOR. THE REMOTE MONITOR IS EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11076119 ↗
• MalfunctionSep 21, 2020Overheating of Device; Overheating of Device

  THE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10564204 ↗
• MalfunctionMar 24, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR OVERHEATED. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. 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 9872339 ↗
• MalfunctionNov 25, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR OVERHEATED. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. 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 9370797 ↗
• MalfunctionJun 25, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE POWER CORD WAS "RED HOT," AND THE PATIENT HAD UNPLUGGED THE REMOTE MONITOR. IT WAS FOUND OUT THAT THERE HAD BEEN A COUPLE OF POWER SURGES IN THE AREA. THE PATIENT WAS GUIDED THROUGH A MANUAL TRANSMISSION. THE REMOTE MONITOR REMAINS IN USE. 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 8730862 ↗
• MalfunctionMay 9, 2019Overheating of Device; Overheating of Device

  THE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8595260 ↗
• MalfunctionMar 8, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR BURST INTO FLAMES. 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 8404349 ↗
• MalfunctionJan 7, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS CAUGHT ON FIRE. 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 8221168 ↗
• MalfunctionOct 31, 2018Break; Break

  IT WAS REPORTED THAT THE METAL PIECE CAME OFF THE POWER CORD OF THE REMOTE MONITOR. NO TROUBLESHOOTING INDICATED. THE POWER CORD WILL BE REPLACED. 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 8023853 ↗
• MalfunctionDec 7, 2017Overheating of Device; Overheating of Device

  THE MONITOR WAS REPLACED AND RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7093268 ↗
• MalfunctionOct 6, 2017Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS HOT. THE CALLER WAS ADVISED THAT THE MONITOR COULD BE WARM BUT SHOULD NOT BE HOT TO TOUCH. THE CALLED STATED THAT THE MONITOR DID NOT FEEL NORMAL. A NEW MONITOR WAS ORDERED FOR THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6924624 ↗
• MalfunctionOct 6, 2017Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE REMOTE MONITOR READER WAS GETTING TOO HOT TO TOUCH. THAT PATIENT WAS ASKED IF IT WAS WARMER THAN NORMAL ELECTRONICS WOULD GET AND THE PATIENT RESPONDED YES. THE PATIENT WAS ADVISED TO DISCONNECT FOR AT LEAST 20 MINUTES AND GIVE IT TIME TO COOL DOWN AND CALL BACK IF THE ISSUE CONTINUES. THE MONITOR IS STILL 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 6923293 ↗
• MalfunctionOct 6, 2017Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem

  IT WAS REPORTED BY THE PATIENT THAT THE REMOTE MONITOR EXPLODED BLUE FLUID WHICH LEAKED ALL OVER THE TABLE AND ONTO THE CARPET. 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 6920296 ↗
• MalfunctionOct 6, 2017Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT'S SPOUSE RETURNED THE MONITOR TO THE CLINIC STATING THAT IT WAS TOO HOT TO TOUCH AND THEY DID NOT FEEL COMFORTABLE HAVING THE MONITOR IN THE HOME. A NEW MONITOR WAS ORDERED FOR THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6920036 ↗
• MalfunctionSep 20, 2017Overheating of Device; Overheating of Device

  IT WAS FURTHER REPORTED THAT THE MONITOR HAS BEEN REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6880400 ↗
• MalfunctionAug 9, 2017Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE BOTTOM OF THE REMOTE MONITOR BASE WAS VERY HOT AND THE PATIENT'S FINGER WOULD HAVE BEEN BURNED IF IT WAS TOUCHED. THE PATIENT UNPLUGGED THE MONITOR BUT AFTER PLUGGING IT IN AGAIN THE MONITOR WAS HOT AFTER A COUPLE HOURS AND EVEN THE READER WAS WARM. A NEW MONITOR WAS ORDERED FOR THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6781306 ↗
• MalfunctionFeb 9, 2017Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE REMOTE MONITOR DISPLAYED AN ERROR CODE INDICATING THE READER IS OFF THE MONITOR BASE AND HAS POWERED DOWN, IS OFF THE BASE STATION AND HAS NO BATTERY LIFE REMAINING OR THE READER IS OUT OF RANGE OF THE MONITOR. IT WAS ALSO REPORTED THAT THE READER SHOCKED THE PATIENT TWICE. THE PATIENT WAS INFORMED HOW TO CLEAR THE ERROR AND THAT THE READER IS NOT ABLE TO SHOCK THE PATIENT AS IT ONLY COLLECTS DATA. 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 6318398 ↗
• MalfunctionDec 9, 2016Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT HAD QUESTIONS ABOUT HOW TO WORK THE HAND HELD ACTIVATOR AND WAS SHOCKED BY THE REMOTE MONITOR WHEN THE READER WAS PLACED AGAINST THE DEVICE. THE PATIENT WAS ADVISED TO CONTACT THE CLINIC AND EDUCATED THAT THE MONITOR AND DEVICE DO NOT HAVE ANY TYPE OF SHOCK THERAPY THAT IT PROVIDES TO THE PATIENT. THE MONITOR AND DEVICE ARE STILL IN USE AND THE PATIENT HAS HAD SEVERAL SUCCESSFUL TRANSMISSIONS SINCE THE DATE OF THE CALL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Electric Shock; Shock

  MAUDE report 6162417 ↗

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-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-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-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-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