Azure™ S DR MRI SureScan™ W3DR01 (UDI 00643169634602)Recalls & reported problems

Summary

The FDA's MAUDE database contains 715 adverse event reports that list this exact device (DI 00643169634602), received between Apr 10, 2018 and Sep 10, 2026 — classified as 12 deaths, 411 injuries, 292 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (84 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 715 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Medical device site infection

  MAUDE report 50542917 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR HEART RATE WAS ''ALL OVER THE PLACE'' AND THAT THEY HAD BEEN HOSPITALIZED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 25605920 ↗
• MalfunctionMay 27, 2026False Alarm

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE ATRIAL LOW LEAD 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 25301441 ↗
• MalfunctionMay 21, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT CONNECTION OF THE PATIENT CONNECTOR TO THE MOBILE PROGRAMMER APPLICATION COULD NOT BE COMPLETED WHILE ATTEMPTING TO REMOVE AN IMPLANTABLE PULSE GENERATOR (IPG) FROM MAGNETIC RESONANCE IMAGING (MRI) MODE. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE TOGGLING BLUETOOTH, FORCE CLOSING THE APPLICATION, ATTEMPTING PAIRING MULTIPLE TIMES UNTIL BLUETOOTH PAIRING WAS ACHIEVED. IT WAS THEN NOTED THAT THE CONNECTOR WAS UNABLE TO CONNECT TO THE IPG REMAINING ON THE LOOKING FOR DEVICE SCREEN. ADDITIONAL TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE REPOSITIONING THE CONNECTOR OVER THE IPG AND REBOOTING THE HOST TABLET; HOWEVER, THE ISSUE PERSISTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242331 ↗
• MalfunctionMay 19, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. UPON DEVICE ASSESSMENT IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING, TRIGGERING ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) DETECTIONS. REPORTS OF HEART RATES IN THE TWENTIES WERE REPORTED, WITH POSSIBLE NON-CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 25214152 ↗
• MalfunctionApr 9, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED HIGHER BATTERY DRAIN. THE IPG REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND POSSIBLE NOISE ON EPISODES RESULTING IN INHIBITION OF PACING AND MISCLASSIFICATION OF EPISODE TYPE. IT WAS REPORTED THAT THE RA LEAD EXHIBITED INTERMITTENT UNDERSENSING ON STORED EPISODES RESULTING IN MISCLASSIFICATION OF A NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODE, TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTED EVENTS IN PROGRESS, AND UNNECESSARY PACING AT TIMES. THE RA LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH NUMBER OF SHORT V-V INTERVALS. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 24832323 ↗
• MalfunctionApr 1, 2026Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE PULSE GENERATOR (IPG) IS NOT PACING THEIR HEART WHEN IT SHOULD AND THAT IT MAY NOT BE WORKING APPROPRIATELY. 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 24752316 ↗
• DeathMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT DIED DUE TO ASPIRATION PNEUMONIA ACUTE HYPOXIC RESPIRATORY FAILURE AND WAS NOT DEVICE RELATED.

  Patient problems: Chest Pain; Insufficient Information

  MAUDE report 24713790 ↗
• MalfunctionMar 24, 2026Pacing Problem

  THE PATIENT REPORTED THAT THEIR APPLE WATCH SHOWS HEART RATE READINGS IN THE FORTIES. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 24680882 ↗
• InjuryMar 23, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IPG WAS EXPLANTED AND THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED FOR AN UNKNOWN REASON. THE IPG AND LEAD WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24659788 ↗
• InjuryMar 19, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A FRACTURE, INTERMITTENT CAPTURE AND NOISE SENSING. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A FRACTURE, RISING PACING IMPEDANCE AND HIGH THRESHOLDS. THE RA AND RV LEADS WERE EXPLANTED AND WERE REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE IPG WAS EXPLANTED AND WAS REPLACED FOR UNKNOWN REASONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637271 ↗
• MalfunctionFeb 13, 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 24332229 ↗
• InjuryJan 26, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED AS THE BATTERY HAD DEPLETED AFTER BEING IMPLANTED LESS THAN SIX YEARS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177096 ↗
• InjuryJan 9, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. THE RV 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 24019955 ↗
• InjuryJan 9, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD PRESSURE. THE PATIENT WAS ADMINISTERED MEDICATION AND THEN THE PATIENT'S HEART RATE DROPPED TO THIRTY SIX BEATS PER MINUTE. THE PATIENT WAS UNSURE OF THE IMPLANTABLE PULSE GENERATOR'S (IPG) FUNCTION. THE IPG REMAINS IN USE. 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; Bradycardia

  MAUDE report 24018867 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ENTEROCOCCUS FAECALIS. 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 23847361 ↗
• MalfunctionDec 3, 2025False Alarm; False Alarm

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNIPOLAR IMPEDANCE OUT OF RANGE. THE RV LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED LOW IMPEDANCE. IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED ANOTHER UNIPOLAR LEAD IMPEDANCE WARNING FOR LOW IMPEDANCE. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) ALSO 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 23704640 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION ON THEIR LEFT LEG. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED FEVER, PAIN, SEPSIS, BACTEREMIA AND VEGETATION WAS NOTED ON AORTIC AND MITRAL VALVES. THE SYSTEM WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Fever; Medical device site infection; Sepsis; Unspecified Infection

  MAUDE report 23093598 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 22792337 ↗
• InjuryJul 11, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A PATIENT THAT THEY EXPERIENCED A "BRIEF BLACKOUT". THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 22478209 ↗
• InjuryJun 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT EXPERIENCED ATRIAL TACHYCARDIA AND FATIGUE. IT WAS ALSO REPORTED THAT MEDICATION WAS ADMINISTERED. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fatigue; Tachycardia

  MAUDE report 22307171 ↗
• MalfunctionJun 23, 2025False Alarm; False Alarm

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE IMPEDANCE ALERT. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A LOW OUT OF RANGE IMPEDANCE. BOTH THE LEAD AND 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 22306974 ↗

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