Azure XT DR MRI SureScanRecalls & reported problems across all models
Medtronic, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14,280
- Deaths reported
- 307
- Injuries reported
- 7,591
- Recalls
- 0
We found 3 models of Azure XT DR MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 14,280 adverse event reports in the FDA's MAUDE database, received between Feb 8, 2018 and Sep 30, 2026 — classified as 307 deaths, 7,591 injuries, 6,382 malfunctions.
The most frequently reported specific device problem is “Pacing Problem” (2,128 reports).
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
Most reported Azure XT DR MRI SureScan problems
Device problems
- Adverse Event Without Identified Device or Use Problem5,152
- Pacing Problem2,128
- Appropriate Device Problem Term/Code Not Available1,867
- Premature Discharge of Battery788
- False Alarm774
- Unable to Obtain Readings677
- Mechanical Problem642
- Reset Problem314
Patient problems
- No Clinical Signs, Symptoms or Conditions4,420
- Unspecified Infection3,535
- Bradycardia1,090
- No Known Impact Or Consequence To Patient1,061
- Erythema443
- Pain424
- No Consequences Or Impact To Patient420
- Syncope/Fainting402
Azure XT DR MRI SureScan models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Azure™ XT DR MRI SureScan™ W1DR01Implantable pulse generator, pacemaker (non-CRT)187 deaths7,655 reports
- Azure™ XT DR MRI SureScan™ W1DR01Implantable pulse generator, pacemaker (non-CRT)107 deaths5,971 reports
- Azure™ XT DR MRI SureScan™ W1DR01Implantable pulse generator, pacemaker (non-CRT)13 deaths654 reports
Recent Azure XT DR MRI SureScan adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Pacing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952501 ↗InjurySep 30, 2026Pacing Problem
Patient problems: Bradycardia; Syncope/Fainting
MAUDE report 50949993 ↗MalfunctionSep 30, 2026Appropriate Device Problem Term/Code Not Available
It was reported by the patient that their Implantable Pulse Generator (IPG) is not connected to them and "I cant talk, weak all the time, feel about to fall". The IPG remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Dizziness; Muscle Weakness/Atrophy
MAUDE report 50946563 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed an infection. The Implantable Pulse Generator (IPG) system was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia; Unspecified Infection
MAUDE report 50946057 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50946046 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed an infection and bacteremia. The Implantable Pulse Generator (IPG) system was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia; Unspecified Infection
MAUDE report 50945956 ↗MalfunctionSep 30, 2026Failure to Interrogate
It was reported by the patient that, "I flagged my bedside machine, I was having Atrial Fibrillation (AF) and had my bag packed to go to the emergency room when I pressed the button. I was having numbness in my head and feeling off. My doctor never called be back, when I asked they said they did not receive anything. Can we please check that?". The Implantable Pulse Generator (IPG) remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Atrial Fibrillation; Numbness
MAUDE report 50945536 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a medical device site infection, discomfort, purulent discharge and bacteremia. The Imp lantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Drug Resistant Bacterial Infection; Medical device site infection; Purulent Discharge
MAUDE report 50944312 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Discomfort; Unspecified Infection
MAUDE report 50934014 ↗InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available
It was reported by the patient that there was impaired healing, and the pocket did not heal properly and the device was exposed. The Implantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Impaired Healing; Pocket Erosion
MAUDE report 50933741 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bacteremia; Drug Resistant Bacterial Infection; Medical device site infection
MAUDE report 50932158 ↗MalfunctionSep 29, 2026Signal Artifact/Noise; Electromagnetic Interference
It was reported that the Implantable Pulse Generator (IPG) exhibited Electromagnetic Interference/Noise. The IPG 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 50931714 ↗MalfunctionSep 29, 2026Appropriate Device Problem Term/Code Not Available
It was reported by the patient that they experienced a problem with their Implantable Pulse Generator (IPG) and a ''red alert'' was noted. The system 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 50931060 ↗MalfunctionSep 29, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Dizziness; High Blood Pressure/ Hypertension
MAUDE report 50930914 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported approximately two month post implant that the patient experienced endocarditis and a Streptococcus gallolyticus infection. The Implantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Bacterial Infection; Endocarditis
MAUDE report 50930640 ↗
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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