Azure™ XT SR MRI SureScan™ W1SR01 (UDI 00763000316709)Recalls & reported problems

Summary

The FDA's MAUDE database contains 469 adverse event reports that list this exact device (DI 00763000316709), received between Mar 29, 2021 and Sep 4, 2026 — classified as 22 deaths, 286 injuries, 161 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (87 reports).

16 other recalls cover devices cleared under the same FDA submission (P980035); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 469 reports, 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 ↗
• 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 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 ↗
• MalfunctionJun 12, 2026Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS ATTEMPTED NOT USED FOR UNKNOWN REASONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485045 ↗
• InjuryMay 28, 2026Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED THEIR PACEMAKER DID NOT "KICK IN" AND THEY "BLACKED OUT" AND HAD TO BE TAKEN TO THE HOSPITAL. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25313159 ↗
• MalfunctionMay 26, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM, THE IPG EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS NOTED THAT THE LONGEVITY ESTIMATE WENT FROM EIGHT YEARS TO FOUR YEARS. 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 25279105 ↗
• InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25270094 ↗
• MalfunctionMay 22, 2026False Alarm

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE RIGHT VENTRICULAR (RV) LEAD LOW IMPEDANCE WARNING. THE IPG REMAINS IN USE. IT WAS NOTED THAT TWO EPICARDIAL LEADS WERE CONNECTED TO THE IPG VIA A Y-ADAPTOR. IT WAS REPORTED THAT THE LEADS EXHIBITED HIGH THRESHOLDS, VARIABLE IMPEDANCE AND OVERSENSING. THE LEADS 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 25255582 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE PATIENT TESTED POSITIVE FOR STAPH. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 25199165 ↗
• InjuryMay 13, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNKNOWN SYMPTOMS AND THE RIGHT VENTRICULAR (RV) LEFT BUNDLE BRANCH LEAD EXHIBITED A LOW VOLTAGE FRACTURE AND X-RAY CONFIRMED THAT THE DEVICE HAD MIGRATED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25159725 ↗
• MalfunctionMay 12, 2026False Alarm

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE LOW VENTRICULAR IMPEDANCE WARNING. 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 25146301 ↗
• MalfunctionMay 7, 2026False Alarm

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE LOW IMPEDANCE WARNING. 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 25110192 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 25110137 ↗
• MalfunctionMay 5, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO TELEMETRY. THE DEVICE 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 25079116 ↗
• InjuryApr 27, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM, THE PATIENT EXPERIENCED DISCOMFORT WITH ARM SWELLING. THE 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: Discomfort; Swelling/ Edema

  MAUDE report 24998021 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P980035. One submission often covers many models, so check the product and lot details in each record.

• Z-2128-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model N
• Z-2127-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D
• Z-1924-2025 · Apr 29, 2025 · Open, Classified
  Azure S DR MRI SureScan, Product number W3DR01
• Z-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• Z-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• Z-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model Number W3DR01
• Z-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• Z-0810-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
• Z-0808-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
• Z-0809-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
• Z-0807-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Numb
• Z-0806-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (
• Z-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• Z-2120-2011 · Apr 4, 2011 · Terminated
  Medtronic, Kappa 600 KDR600,KDR601,KDR603,KDR606,KDR651,KDR653 The devices are implantable pulse generators (IPG) used to detect bradycardia events and provide pacing support. Wit
• Z-1440-2010 · Feb 11, 2010 · Terminated
  Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects,

…and 1 more.