Azure XT SR MRI SureScanRecalls & reported problems across all models

We found 3 models of Azure XT SR MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 911 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2018 and Sep 4, 2026 — classified as 33 deaths, 538 injuries, 340 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (159 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

Most reported Azure XT SR MRI SureScan problems

Azure XT SR MRI SureScan models

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

• Azure™ XT SR MRI SureScan™ W1SR01

  Implantable pulse generator, pacemaker (non-CRT)
  22 deaths469 reports
• Azure™ XT SR MRI SureScan™ W1SR01

  Pulse generator, permanent, implantable
  11 deaths425 reports
• Azure™ XT SR MRI SureScan™ W1SR01

  Pulse generator, permanent, implantable
  17 reports

Recent Azure XT 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.

• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by a patient representative that the patient experienced an infection, some burning sensations after a MRI scan, and hallucinating. The Implantable Pulse Generator (IPG) system remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Burning Sensation; Confusion/ Disorientation; Unspecified Infection

  MAUDE report 50611926 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection and experienced Purulent Discharge/Pus. The Implantable Pulse Generator (IP G) system was explanted with no replacement. No further patient complications have been reported as a result of this event.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 50606764 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that two months post implant, the patient experienced purulent discharge, fever and pain due to a pocket infection. The Implantable Pulse Generator (IPG) system was explanted and replaced with a leadless pacemaker. No further patient complicationshave been reported as a result of this event.

  Patient problems: Fever; Medical device site infection; Pain; Purulent Discharge

  MAUDE report 50590680 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50561722 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection. Staphylococcus aureus noted. The Implantable Pulse Generator (IPG) system was explanted and replaced with a leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 50494574 ↗
• DeathAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during implant of the Implantable Pulse Generator (IPG) system, the patient died due to asystole and respiratory arrest.

  Patient problems: Asystole; Cardiac Arrest

  MAUDE report 50207047 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection. The Implantable Pulse Generator (IPG) system was removed and replaced with a Leadless implantable pulse generator (IPG). No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50139824 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that one month post implant, the patient experienced discomfort, pain and redness due to a systemic infection. The I mplantable Pulse Generator (IPG) system was explanted without replacement. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Erythema; Medical device site infection; Pain

  MAUDE report 50083894 ↗
• InjuryJul 29, 2026Pacing Problem

  It was reported that the Right Atrial (RA) lead, which is place in the right ventricle port, exhibited a possible sensing issue on presenting electrograms (EGM) and short v-v intervals. The RA lead remains un use. It was further reported that the lead exhibited intermittent undersensing on current electrograms (EGM) with false classification/te rmination of ongoing arrhythmias. It was further reported that the patient experienced sinus pause for two minutes with a heart rate in the fifties. Gaps were also observed between the QRS on External Cardiac Monitor. The RA lead exhibited undersensing of Atrial Fibrillation (AF) waves noted resulting in unnecessary pacing at times. The Implantable Pulse Generator (IPG) remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Non specific EKG/ECG Changes

  MAUDE report 50077333 ↗
• InjuryJul 2, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. THE IPG 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 25690553 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25688047 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION FOUR MONTHS POST IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM IMPLANT. THE IPG SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25666273 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT LESS THAN A WEEK POST IMPLANT THAT THEY DEVELOPED A WOUND INFECTION. IT WAS ALSO REPORTED THAT THE PATIENT WAS ON A WOUND-VAC. 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: Medical device site infection

  MAUDE report 25575882 ↗
• MalfunctionJun 15, 2026Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED BRADYCARDIA AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE LOWER RATE. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 25498984 ↗
• MalfunctionJun 15, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE IPG AND RV 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 25498826 ↗

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