MyCareLinkRecalls & reported problems across all models
Medtronic, Inc. · 33 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 798
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 33 models of MyCareLink by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 798 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 17, 2026 — classified as 2 injuries, 796 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (697 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
Reports received per month, all models
MyCareLink 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.
- 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 · names 16 of these models · Recall details · FDA record ↗
Most reported MyCareLink problems
Device problems
- Overheating of Device697
- Device Emits Odor66
- Inappropriate/Inadequate Shock/Stimulation28
- Mechanical Problem12
- Moisture Damage10
- Data Problem3
- Temperature Problem3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions513
- No Known Impact Or Consequence To Patient202
- No Consequences Or Impact To Patient106
- Burn(s)24
- Burning Sensation4
- Shock2
- Chest Pain1
- Electric Shock1
MyCareLink models
33 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MyCareLink™ 24952BPacemaker/icd/crt non-implanted components169 reports
- MyCareLink™ 24950JPulse generator, permanent, implantable1 recall39 reports
- MyCareLink™ 24950KPulse generator, permanent, implantable1 recall38 reports
- MyCareLink™ 24950KLQPulse generator, permanent, implantable1 recall32 reports
- MyCareLink™ 24950JLQPulse generator, permanent, implantable1 recall18 reports
- MyCareLink™ 24950GPacemaker/icd/crt non-implanted components1 recall17 reports
- MyCareLink™ 24950MPulse generator, permanent, implantable65 reports
- MyCareLink™ 24950EPacemaker/icd/crt non-implanted components1 recall12 reports
- MyCareLink™ 24950JPulse generator, permanent, implantable1 recall12 reports
- MyCareLink™ 24950JLQPulse generator, permanent, implantable1 recall10 reports
- MyCareLink™ 24950KLQPulse generator, permanent, implantable1 recall10 reports
- MyCareLink™ 24950GLQPacemaker/icd/crt non-implanted components1 recall7 reports
- MyCareLink™ 24950LPacemaker/icd/crt non-implanted components56 reports
- MyCareLink™ 24950DPacemaker/icd/crt non-implanted components1 recall3 reports
- MyCareLink™ 24950KLQPacemaker/icd/crt non-implanted components1 recall3 reports
- MyCareLink™ 24950JLQPacemaker/icd/crt non-implanted components1 recall2 reports
- MyCareLink™ 24950JLQPulse generator, permanent, implantable1 recall1 report
- MyCareLink™ 24952APacemaker/icd/crt non-implanted components51 reports
- MyCareLink™ 24950DPacemaker/icd/crt non-implanted components1 recall0 reports
- MyCareLink™ 24950D1Pacemaker/icd/crt non-implanted components1 recall0 reports
- MyCareLink™ 24950MPulse generator, permanent, implantable41 reports
- MyCareLink™ 24950LLQPacemaker/icd/crt non-implanted components34 reports
- MyCareLink™ 24950LPulse generator, permanent, implantable32 reports
- MyCareLink™ 24950LLQPacemaker/icd/crt non-implanted components32 reports
- MyCareLink™ 24950LPulse generator, permanent, implantable22 reports
- MyCareLink™ 24950LPulse generator, permanent, implantable22 reports
- MyCareLink™ 24950MPacemaker/icd/crt non-implanted components21 reports
- MyCareLink™ 24950MPacemaker/icd/crt non-implanted components16 reports
- MyCareLink™ 24950MPacemaker/icd/crt non-implanted components13 reports
- MyCareLink™ 24950MPulse generator, permanent, implantable12 reports
- MyCareLink™ 24952BPacemaker/icd/crt non-implanted components4 reports
- MyCareLink™ 24950LLQPacemaker/icd/crt non-implanted components3 reports
- MyCareLink™ 24950MPacemaker/icd/crt non-implanted components1 report
Recent MyCareLink adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Overheating of Device
It was reported that MycareLink remote monitor was overheated. No troubleshooting indicated. A replacement remote monitor was ordered. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50800492 ↗MalfunctionSep 11, 2026Overheating of Device
It was reported that the remote monitor was overheating. No troubleshooting indicated. A replacement monitor was ordered. The 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 50730340 ↗MalfunctionSep 11, 2026Overheating of Device
It was reported that the remote monitor had smoking smell coming from the monitor and unplugged it due to concern for a potential fire. No troubleshooting indicated. replacement monitor was ordered. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50729967 ↗MalfunctionSep 2, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566320 ↗MalfunctionAug 28, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50493879 ↗MalfunctionAug 27, 2026Overheating of Device
It was reported that the MyCareLink remote monitor was overheating. The patient unplugged the monitor. No troubleshooting indicated. Replacement monitor was ordered. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50474515 ↗MalfunctionJul 10, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25775730 ↗MalfunctionJun 19, 2026Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT WAS BEING SHOCKED AND ALLEGED THE MONITOR CAUSED IT. NO TROUBLESHOOTING TAKEN. THE PATIENT WAS ADVISED THAT THE BEDSIDE MONITOR DOES NOT INDUCE ANY THERAPIES BUT RECOMMENDED GETTING THE DEVICE CHECKED AT THE CLINIC. THE MONITOR 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 25560133 ↗MalfunctionMay 11, 2026Overheating of Device
IT WAS REPORTED THAT A REMOTE MONITOR FOR AN IMPLANTABLE CARDIAC MONITOR (ICM) WAS OVERHEATING. NO TROUBLESHOOTING TAKEN. THE MONITOR WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144780 ↗MalfunctionApr 20, 2026Overheating of Device
IT WAS REPORTED THAT THE REMOTE MONITOR WAS OVERHEATING. NO TROUBLESHOOTING TAKEN. MONITOR HAS BEEN REPLACED. NO PATIENT COMPLICATIO NS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24925112 ↗MalfunctionMar 6, 2026Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24532654 ↗MalfunctionJan 22, 2026Overheating of Device
IT WAS REPORTED THAT A REMOTE MONITOR STARTED SMOKING. THE PATIENT UNPLUGGED THE MONITOR, AND NO FURTHER TROUBLESHOOTING WAS TAKEN. A NEW MONITOR WAS ORDERED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24144134 ↗MalfunctionDec 4, 2025Overheating of Device; Overheating of Device
IT WAS REPORTED THAT A REMOTE MONITOR FOR A DEFIBRILLATOR HAD BEEN OVERHEATING FOR ABOUT A MONTH. NO TROUBLESHOOTING TAKEN. THE MONITOR WILL BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715938 ↗MalfunctionNov 3, 2025Overheating of Device; Overheating of Device
THE MONITOR WAS RETURNED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452078 ↗MalfunctionOct 15, 2025Overheating of Device; Overheating of Device
THE REMOTE MONITOR WAS REPLACED AND RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23293899 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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