Azure S DR MRI SureScanRecalls & reported problems across all models

We found 3 models of Azure S DR MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,200 adverse event reports in the FDA's MAUDE database, received between Apr 10, 2018 and Sep 23, 2026 — classified as 14 deaths, 722 injuries, 464 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (133 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 S DR MRI SureScan problems

Azure S DR MRI SureScan models

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

• Azure™ S DR MRI SureScan™ W3DR01

  Implantable pulse generator, pacemaker (non-CRT)
  12 deaths715 reports
• Azure™ S DR MRI SureScan™ W3DR01

  Implantable pulse generator, pacemaker (non-CRT)
  2 deaths443 reports
• Azure™ S DR MRI SureScan™ W3DR01

  Implantable pulse generator, pacemaker (non-CRT)
  42 reports

Recent Azure S 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.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a Methicillin-resistant Staphylococcus aureus (MRSA) infection, sepsis and septic shock. The Implantable Pulse Generator (IPG) was explanted and replaced with a leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Bacterial Infection; Drug Resistant Bacterial Infection; Sepsis; Septic Shock; Unspecified Infection

  MAUDE report 50865296 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection and endocarditis. 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: Endocarditis; Unspecified Infection

  MAUDE report 50816497 ↗
• MalfunctionSep 10, 2026Pacing Problem

  It was reported that the patient experienced bradycardia. It was also reported that the Implantable Pulse Generator (IPG) was pacing below the lower limit. The IPG remains in use . No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia

  MAUDE report 50709306 ↗
• InjurySep 10, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Implantable Pulse Generator (IPG) was removed and replaced for an unknown reason. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50708960 ↗
• MalfunctionSep 9, 2026Migration or Expulsion of Device

  It was reported by the patient that the Implantable Pulse Generator (IPG) moved and was protruding and they pushed it back into place. 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 50688278 ↗
• InjurySep 9, 2026Premature Discharge of Battery

  It was reported that the Right Atrial (RA) lead and Right Ventricular (RV) lead exhibited high thresholds. The leads were explanted and replaced. No patient complications have been reported as a result of this event. It was further reported that that the Implantable Pulse Generator (IPG) was explanted and replaced due to early battery depletion due to high thresholds.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50685812 ↗
• MalfunctionSep 2, 2026Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50560574 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection

  MAUDE report 50542917 ↗
• MalfunctionAug 31, 2026Appropriate Device Problem Term/Code Not Available

  The patient reported that they experienced chest pain and light-headedness. They also reported that there was an "issue" with their pacemaker. The Implantable Pulse Generator (IPG) remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Chest Pain; Dizziness

  MAUDE report 50516439 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was further reported by the patient that they are still in "tremendous pain" and "Something feels squeezed in my chest behind the pacemaker". They also stated "It feels like it's breaking a rib or 2. I'm out of breath" and "my belly is always moving, turning, turning. It's pulling my chest inwards and moving my involuntarily, it's controlling my body and moving up close to my throat". No further patient complications have been reported as a result of this event.

  Patient problems: Chest Pain; Discomfort; Dyspnea; Pain

  MAUDE report 50272469 ↗
• MalfunctionAug 6, 2026Appropriate Device Problem Term/Code Not Available

  It was reported approximately six months post implant that patient stated "this pacemaker does not work, my pulse runs from 56 to 126". The Implantable Pulse Generator (IPG) remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Tachycardia

  MAUDE report 50154567 ↗
• MalfunctionAug 4, 2026False Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50127051 ↗
• MalfunctionJul 31, 2026False Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096577 ↗
• MalfunctionJul 28, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053772 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST IMPLANT THE PATIENT DEVELOPED A POCKET INFECTION ALONG WITH EROSION, DISCOMFORT AND PURULENT DISCHARGE/PUS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED BY A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 25733474 ↗

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