Azure™ S DR MRI SureScan™ W3DR01 (UDI 00763000316693)Recalls & reported problems

Summary

The FDA's MAUDE database contains 443 adverse event reports that list this exact device (DI 00763000316693), received between Mar 8, 2021 and Sep 23, 2026 — classified as 2 deaths, 289 injuries, 152 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (44 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 443 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a Methicillin-resistant Staphylococcus aureus (MRSA) infection, sepsis and septic shock. The Implantable Pulse Generator (IPG) was explanted and replaced with a leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Bacterial Infection; Drug Resistant Bacterial Infection; Sepsis; Septic Shock; Unspecified Infection

  MAUDE report 50865296 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection and endocarditis. 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: Endocarditis; Unspecified Infection

  MAUDE report 50816497 ↗
• MalfunctionSep 10, 2026Pacing Problem

  It was reported that the patient experienced bradycardia. It was also reported that the Implantable Pulse Generator (IPG) was pacing below the lower limit. The IPG remains in use . No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia

  MAUDE report 50709306 ↗
• MalfunctionSep 2, 2026Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50560574 ↗
• MalfunctionAug 31, 2026Appropriate Device Problem Term/Code Not Available

  The patient reported that they experienced chest pain and light-headedness. They also reported that there was an "issue" with their pacemaker. The Implantable Pulse Generator (IPG) remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Chest Pain; Dizziness

  MAUDE report 50516439 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was further reported by the patient that they are still in "tremendous pain" and "Something feels squeezed in my chest behind the pacemaker". They also stated "It feels like it's breaking a rib or 2. I'm out of breath" and "my belly is always moving, turning, turning. It's pulling my chest inwards and moving my involuntarily, it's controlling my body and moving up close to my throat". No further patient complications have been reported as a result of this event.

  Patient problems: Chest Pain; Discomfort; Dyspnea; Pain

  MAUDE report 50272469 ↗
• MalfunctionAug 6, 2026Appropriate Device Problem Term/Code Not Available

  It was reported approximately six months post implant that patient stated "this pacemaker does not work, my pulse runs from 56 to 126". 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 50154567 ↗
• MalfunctionAug 4, 2026False Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50127051 ↗
• MalfunctionJul 31, 2026False Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096577 ↗
• MalfunctionJul 28, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053772 ↗
• InjuryJul 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST IMPLANT THE PATIENT DEVELOPED A POCKET INFECTION ALONG WITH EROSION, DISCOMFORT AND PURULENT DISCHARGE/PUS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED BY A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 25733474 ↗
• MalfunctionJun 22, 2026False Alarm

  IT WAS REPORTED THAT THERE WAS A FALSE LOW IMPEDANCE WARNING ON THE IMPLANTABLE PULSE GENERATOR (IPG). 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 25574259 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. VEGETATION WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 25445697 ↗
• MalfunctionJun 8, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE TURNED OFF AND CAN'T SEND A SIGNAL TO THE HEART. 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 25424465 ↗
• InjuryJun 8, 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 WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25424046 ↗
• MalfunctionMay 28, 2026False Alarm

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE LOW IMPEDANCE WARNING. 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 25315725 ↗
• MalfunctionMay 18, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT ESTABLISH A TELEMETRY SESSION. 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 25201988 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHORTLY AFTER IMPLANT, THE RIGHT ATRIAL (RA) LEAD HAD DISLODGEMENT. THE RA LEAD WAS EXPLANTED AND REPLACED. THE PATIENT FURTHER STATED THAT THEY EXPERIENCED POSSIBLE 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 25165326 ↗
• InjuryMay 7, 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25110063 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY SEVEN WEEKS POST IMPLANT THAT THE PATIENT EXPERIENCED A POCKET INFECTION, PURULENT DISCHARGE, REDNESS AND WOUND DEHISCENCE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection; Purulent Discharge; Wound Dehiscence

  MAUDE report 25091867 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POCKET INFECTION. IT WAS ALSO NOTED THAT THE PATIENT HAD TWIDDLERS SYNDROME AND EXPERIENCED PHRENIC STIMULATION AS THE LEADS PULLED BACK. 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: Medical device site infection

  MAUDE report 25042906 ↗
• MalfunctionApr 30, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION DUE TO HIGH RIGHT VENTRICULAR (RV) LEFT BUNDLE BRANCH LEAD OUTPUTS. THE LEAD WAS PREVIOUSLY REPROGRAMMED TO IMPROVE CAPTURE. THE IPG AND 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 25042047 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM, THE PATIENT EXPERIENCED BRUISING. SIMILARLY, ONE APPROXIMATELY ONE MONTH LATER THE PATIENT EXPERIENCED BRUISING ACROSS THEIR CHEST, UNDER THEIR ARMPIT, AND ACROSS THEIR BACK. IT WAS NOTED THAT THE PATIENT ALSO EXPERIENCED PAIN. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE 6 WEEKS POST IMPLANT THE PATIENT EXPERIENCED DEEP VEIN THROMBOSIS WITH SYMPTOMS OF EDEMA, PURPLE DISCOLORATION AND NUMBNESS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE IPG SYSTEM REMAINS IN USE.

  Patient problems: Bruise/Contusion; Numbness; Pain; Skin Discoloration; Thrombosis/Thrombus

  MAUDE report 24981469 ↗
• InjuryApr 9, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND THE IMPLANTABLE PULSE GENERATOR (IPG) HAD PREMATURE BATTERY DEPLETION TO THE HIGH PROGRAMMED OUTPUTS. THE IPG WAS EXPLANTED AND REPLACED. THE RV LEAD WAS REPROGRAMMED 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 24828217 ↗
• MalfunctionApr 8, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST-IMPLANT, THE PATIENT RAISED A CONCERN REGARDING THE IMPLANTABLE PULSE GENERATOR (IPG), ASKING, ¿IS IT WORKING PROPERLY¿ AND ¿DID IT DISLODGE SOMETHING.¿ 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 24814204 ↗

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-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-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-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-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• 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-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-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.