Medtronic Azure PacemakerRecalls & reported problems across all models

We found 12 models of Medtronic Azure Pacemaker by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 16,566 adverse event reports in the FDA's MAUDE database, received between Feb 8, 2018 and Sep 30, 2026 — classified as 366 deaths, 8,970 injuries, 7,230 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (2,438 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 Medtronic Azure Pacemaker problems

Medtronic Azure Pacemaker models

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

• Azure™ XT DR MRI SureScan™ W1DR01

  Implantable pulse generator, pacemaker (non-CRT)
  187 deaths7,655 reports
• Azure™ XT DR MRI SureScan™ W1DR01

  Implantable pulse generator, pacemaker (non-CRT)
  107 deaths5,971 reports
• Azure™ S DR MRI SureScan™ W3DR01

  Implantable pulse generator, pacemaker (non-CRT)
  12 deaths715 reports
• Azure™ XT DR MRI SureScan™ W1DR01

  Implantable pulse generator, pacemaker (non-CRT)
  13 deaths654 reports
• Azure™ XT SR MRI SureScan™ W1SR01

  Implantable pulse generator, pacemaker (non-CRT)
  22 deaths469 reports
• Azure™ S DR MRI SureScan™ W3DR01

  Implantable pulse generator, pacemaker (non-CRT)
  2 deaths443 reports
• Azure™ XT SR MRI SureScan™ W1SR01

  Pulse generator, permanent, implantable
  11 deaths425 reports
• Azure™ S SR MRI SureScan™ W3SR01

  Implantable pulse generator, pacemaker (non-CRT)
  7 deaths86 reports
• Azure™ S SR MRI SureScan™ W3SR01

  Implantable pulse generator, pacemaker (non-CRT)
  5 deaths83 reports
• Azure™ S DR MRI SureScan™ W3DR01

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

  Pulse generator, permanent, implantable
  17 reports
• Azure™ S SR MRI SureScan™ W3SR01

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

Recent Medtronic Azure Pacemaker 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 ↗
• 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 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 ↗

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