Azure™ XT DR MRI SureScan™ W1DR01 (UDI 00643169634589)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,971 adverse event reports that list this exact device (DI 00643169634589), received between Feb 8, 2018 and Sep 29, 2026 — classified as 107 deaths, 2,951 injuries, 2,913 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (737 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 5,971 reports, in the reporter's own words as published by the FDA.

• 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, 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 28, 2026Electromagnetic Interference

  It was reported that the Right Atrial (RA) lead exhibited oversensing. It was further reported that the Implantable Pulse Generator (IPG) exhibited Electromagnetic Interference. 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 50911825 ↗
• InjurySep 24, 2026Premature Discharge of Battery

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds and the Implantable Pulse Generator (IPG) exhibited early battery depletion. The RV lead remains in use and 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 50882075 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a systemic infection. The organism was identified as methicillin-resistant staphylococcus aureus. It was further reported that the Right Atrial (RA) lead exhibited vegetation. The Implantable Pulse Generator (IPG) system was explanted and replaced with a leadless pacemaker. No further patient complications have been reported as a result of this event.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 50882047 ↗
• InjurySep 24, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the patient experienced chest pain. Medication was administered as a result. No further patient complications have been reported as a result of this event.

  Patient problems: Chest Pain

  MAUDE report 50881196 ↗
• InjurySep 18, 2026Premature Discharge of Battery

  It was reported by the patient that the Right Atrial (RA) lead was 'not working properly'. It was also reported that the Implantable Pulse Generator (IPG) exhibited premature battery depletion. The RA lead was capped and replaced. 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 50817242 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's heart rate got "pretty high" and had to go 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: Tachycardia

  MAUDE report 50802476 ↗
• MalfunctionSep 16, 2026False Alarm

  It was reported that the Implantable Pulse Generator (IPG) exhibited a false low impedance warning on the Right Ventricular (RV) lead. 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 50787761 ↗
• MalfunctionSep 15, 2026False Alarm

  It was reported that Implantable Pulse Generator (IPG) exhibited a false Right Atrial (RA) lead 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 50774403 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Right Ventricular (RV) lead exhibited rising impedance, high impedance, high thresholds. The RV lead was su spected to be fractured. The RV lead was reprogrammed and later explanted. It was further noted that the patient experienced a systemic infection. The IPG system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50768294 ↗
• MalfunctionSep 14, 2026Mechanical Problem

  It was reported that the Right Ventricular (RV) lead exhibited a large number of Sensing Integrity Counter (SIC), cross chamber oversensing, and chronic high thresholds post reprogramming. A possible setscrew issue was suspected. 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 50752799 ↗
• InjurySep 11, 2026Premature Discharge of Battery

  It was reported that the Implantable Pulse Generator (IPG) exhibited premature battery depletion. 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 50730283 ↗
• InjurySep 4, 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 with no replacement. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50607328 ↗
• MalfunctionSep 2, 2026Pacing Problem

  Patient problems: Arrhythmia; Bradycardia; Dyspnea; Non specific EKG/ECG Changes; Palpitations

  MAUDE report 50563654 ↗
• MalfunctionSep 1, 2026Pacing Problem

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

  MAUDE report 50543722 ↗
• MalfunctionSep 1, 2026Pacing Problem

  Patient problems: Bradycardia

  MAUDE report 50543678 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 50540252 ↗
• InjuryAug 31, 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 50516515 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection and experienced discomfort, erosion, pain and redness. 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: Discomfort; Erosion; Erythema; Pain; Unspecified Infection

  MAUDE report 50516327 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the patient that they had experienced Atrial Fibrillation (AF). The patient underwent a cardioversion and the Implantable Pulse Generator (IPG) was reprogrammed. The IPG remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Atrial Fibrillation

  MAUDE report 50492878 ↗
• MalfunctionAug 27, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Implantable Pulse Generator (IPG) was firing. 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 50469826 ↗
• MalfunctionAug 26, 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 50447835 ↗
• InjuryAug 26, 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 with no replacement. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 50447679 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection and vegetation. The Implantable Pulse Generator (IPG) system was explanted with no replacement. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection

  MAUDE report 50318548 ↗

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-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• Z-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model Number W3DR01
• Z-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• 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-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-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-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• 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-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-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.