Azure S SR 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
- 175
- Deaths reported
- 12
- Injuries reported
- 119
- Recalls
- 0
We found 3 models of Azure S SR MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 175 adverse event reports in the FDA's MAUDE database, received between Apr 2, 2018 and Sep 29, 2026 — classified as 12 deaths, 119 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Pacing Problem” (18 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 S SR MRI SureScan problems
Device problems
- Adverse Event Without Identified Device or Use Problem98
- Pacing Problem18
- Appropriate Device Problem Term/Code Not Available17
- Failure to Interrogate7
- Mechanical Problem7
- Premature Discharge of Battery6
- False Alarm4
- Failure to Capture3
Patient problems
- Unspecified Infection67
- No Clinical Signs, Symptoms or Conditions40
- Bradycardia11
- Pocket Erosion11
- Discomfort10
- Erythema10
- Erosion7
- Bacteremia6
Azure S SR MRI SureScan models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Azure™ S SR MRI SureScan™ W3SR01Implantable pulse generator, pacemaker (non-CRT)7 deaths86 reports
- Azure™ S SR MRI SureScan™ W3SR01Implantable pulse generator, pacemaker (non-CRT)5 deaths83 reports
- Azure™ S SR MRI SureScan™ W3SR01Implantable pulse generator, pacemaker (non-CRT)6 reports
Recent Azure S SR 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 29, 2026Failure to Interrogate
It was reported by the patient that they had trouble "hooking up the device for transmitting". The Implantable Pulse Generator (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 50933106 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed an infection. and experienced redness. 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: Erythema; Unspecified Infection
MAUDE report 50537844 ↗InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed a Staphylococcus aureus bacterial infection approximately one month post Implantable Pulse Generator (IPG) implant with resulting erythema and bacteremia. The IPG system was explanted and replaced with a Leadless implantable pulse generator (IPG). No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia; Bacterial Infection; Erythema
MAUDE report 50127877 ↗MalfunctionMay 5, 2026False Alarm
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE IMPEDANCE WARNING. THE IPG AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25080671 ↗DeathApr 20, 2026Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT PASSED AWAY IN THEIR SLEEP. THE FAMILY MEMBERS OF THE PATIENT FELT THAT THE IMPLANTABLE PULSE GENERATOR (IPG) MALFUNCTIONED AND WERE QUESTIONING THE PACEMAKER FUNCTION. ADDITIONAL INFORMATION RELATED TO THE CAUSE OF THEIR DEATH WAS NOT AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 24925698 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION. THE ORGANISM WAS IDENTIFIED AS METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS. THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE RIGHT ATRIAL (RA) LEAD WERE EXPLANTED WITHOUT REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Bacterial Infection; Medical device site infection
MAUDE report 24830402 ↗InjuryFeb 25, 2026Premature Discharge of Battery
IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24442919 ↗InjuryJan 9, 2026Pacing Problem
IT WAS NOTED THAT THE IPG WAS EXPLANTED AND REPLACED.
Patient problems: Discomfort; Dyspnea
MAUDE report 24020088 ↗DeathJan 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS FURTHER REPORTED THAT THE PATIENT PASSED AWAY ONE DAY POST EXPLANT.
Patient problems: Fluid Discharge; Pocket Erosion; Unspecified Infection
MAUDE report 24019733 ↗MalfunctionDec 19, 2025False Alarm; False Alarm
IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED FALSE RIGHT VENTRICULAR (RV) LEAD LOW IMPEDANCE ALERT. 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 23848428 ↗InjuryNov 17, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23566394 ↗InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION IN THE PACEMAKER POCKET ALONG WITH PURULENT DISCHARGE/PUS AND REDNESS. IT WAS NOTED THAT THE ORGANISM OF INFECTION WAS STAPHYLOCOCCUS AUREUS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Bacterial Infection; Erythema; Medical device site infection; Purulent Discharge
MAUDE report 23355712 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEPSIS DUE TO A BACTEREMIA INFECTION. THE ORGANISM WAS IDENTIFIED AS E. COLI. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Bacteremia; Sepsis; Unspecified Infection
MAUDE report 23278936 ↗InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH FEVER AND THERE WAS REDNESS ALSO. THE PATIENT WAS IN DISCOMFORT AS WELL. IT WAS ALSO REPORTED THAT THE PATIENT HAD AN INFECTION AND THE ORGANISM WAS CANDIDA AURIS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Discomfort; Erythema; Fever; Fungal Infection
MAUDE report 23084369 ↗InjurySep 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS FURTHER REPORTED THAT THE IPG SYSTEM WAS EXPLANTED DUE TO METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS BACTEREMIA. VEGETATION WAS NOTED ON THE RV LEAD. THE PATIENT DEVELOPED MRSA PNEUMONIA AND CULTURES CONFIRMED MRSA. ANTIBIOTICS WERE ADMINISTERED AND A NEW LEADLESS IPG WAS PLACED.
Patient problems: Drug Resistant Bacterial Infection; No Clinical Signs, Symptoms or Conditions; Pneumonia
MAUDE report 23049442 ↗
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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