Azure™ XT DR MRI SureScan™ W1DR01 (UDI 00763000316846)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7,655 adverse event reports that list this exact device (DI 00763000316846), received between Feb 2, 2021 and Sep 30, 2026 — classified as 187 deaths, 4,307 injuries, 3,161 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (1,299 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 7,655 reports, 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, 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

  Patient problems: Dizziness; High Blood Pressure/ Hypertension

  MAUDE report 50930914 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported approximately two month post implant that the patient experienced endocarditis and a Streptococcus gallolyticus infection. The Implantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Bacterial Infection; Endocarditis

  MAUDE report 50930640 ↗
• InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930482 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that there was a pocket infection. The Implantable Pulse Generator (IPG) remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50930306 ↗
• InjurySep 29, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928935 ↗
• MalfunctionSep 29, 2026Premature Discharge of Battery

  It was reported that the Right Atrial (RA) lead exhibited low impedance values contributing to premature depletion of the Implantable Pulse Generator (IPG) battery. The lead was reporgrammed and 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 50928916 ↗
• MalfunctionSep 29, 2026False Alarm

  It was reported one day post implant 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 50928689 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced chest pain and wound dehiscence. The Implantable Pulse Generator (IPG) system remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Chest Pain; Wound Dehiscence

  MAUDE report 50928469 ↗
• MalfunctionSep 28, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916412 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 50916366 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection and experienced swelling. The Implantable Pulse Generator (IPG) was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 50913003 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection and a fever. 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: Fever; Unspecified Infection

  MAUDE report 50912906 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported twelve days post implant that the patient experienced pocket infection. It was also reported that the patient experienced swelling, redness and discomfort. The Implantable Pulse Generator (IPG) was revised and remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Erythema; Medical device site infection; Swelling/ Edema

  MAUDE report 50912511 ↗
• MalfunctionSep 28, 2026Pacing Problem

  It was reported that the patient was feeling well and their Implantable Pulse Generator (IPG) was pacing below the lower rate. The IPG remains in use. No 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 50912415 ↗

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-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-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-1924-2025 · Apr 29, 2025 · Open, Classified
  Azure S DR MRI SureScan, Product number W3DR01
• Z-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model 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-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• 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-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-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-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-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.