MyCareLink SmartRecalls & reported problems across all models

We found 3 models of MyCareLink Smart by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Sep 11, 2018 and Feb 13, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (3 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

MyCareLink Smart recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-0400-2018 · Root cause: Error in labeling · names 2 of these models · Recall details · FDA record ↗

Most reported MyCareLink Smart problems

MyCareLink Smart models

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

• MyCareLink Smart™ 25000

  CONTAINER, SPECIMEN, STERILE
  1 recall5 reports
• MyCareLink Smart™ 25000

  CONTAINER, SPECIMEN, STERILE
  1 recall0 reports
• MyCareLink Smart™ 25000

  CONTAINER, SPECIMEN, STERILE
  1 report

Recent MyCareLink Smart adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Overheating of Device

  IT WAS REPORTED THAT THE MYCARELINK SMART READER WAS OVERHEATING AND A BURNING SENSATION ON THE CHEST WAS EXPERIENCED BY THE PATIENT WHILE USING IT. NO TROUBLESHOOTING TAKEN. THE RESOLUTION WAS TO REPLACE THE SMART READER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333630 ↗
• MalfunctionSep 12, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE READER WAS LEAKING ACID. THE PATIENT LEFT THE BATTERIES IN AND WAS ADVISED TO TAKE OUT THE BATTERIES AFTER USING THE READER, SO IT DOES NOT GET DAMAGED BY CORROSION. THE READER 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 23036695 ↗
• MalfunctionJun 23, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SMART READER'S BATTERY WAS LEAKING. THE READER WAS CLEANED WELL BUT STILL WAS NOT WORKING. THE SMART READER 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 22306563 ↗
• MalfunctionJan 25, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT AFTER OPENING THE BOX FOR THE MOBILE READER, THE PATIENT HAD A REACTION FROM THE ODOR AND IT FELT LIKE THE PATIENT'S LIPS WERE SWELLING ALTHOUGH THEY WERE NOT SWOLLEN. THE PATIENT ALSO REPORTED THAT WHEN TAKING THE MONITOR OUT OF THE BOX, THE PATIENT STARTED GETTING MILD ELECTRICITY IN THE HANDS AND WHEN INHALING IT COULD BE FELT IN THE BODY. THE PATIENT NOTED THAT GOING INTO THE CLINIC TO HAVE THE DEVICE CHECKED DOES NOT GIVE THE PATIENT ANY REACTION. THE PATIENT REPORTED HAVING THE SAME REACTION TO OTHER ELECTRONICS. THE PATIENT WAS REFERRED TO THE CLINIC TO DISCUSS AND WILL BE RETURNING THE MONITOR. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Electric Shock; Swelling/ Edema

  MAUDE report 11223780 ↗
• MalfunctionApr 9, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE MOBILE READER WAS OVERHEATING ONCE THE BATTERIES WERE PUT IN TO HAVE THE READING DONE. A NEW READER WAS SENT TO 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 9944195 ↗
• MalfunctionSep 11, 2018Overheating of Device; Overheating of Device

  IT WAS REPORTED BY THE CALLER THAT WHEN THE PATIENT PLACED THE READER OVER THE IMPLANTED DEVICE THE PATIENT PULLED THE READER AWAY WHILE PERFORMING A TRANSMISSION BECAUSE IT FELT LIKE IT WAS BURNING THE PATIENT¿S SKIN. WHEN THE PATIENT WAS ASKED IF THE READER WAS HOT TO TOUCH, THE PATIENT SAID IT WAS LIKE A MATCH WAS LIT NEXT TO HER SKIN. THE PATIENT WAS REFERRED TO THE CLINIC AND THE READER 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 7864761 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
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• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
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• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls