Azure™ S SR MRI SureScan™ W3SR01 (UDI 00643169634640)Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 00643169634640), received between Apr 2, 2018 and Apr 20, 2026 — classified as 7 deaths, 61 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (6 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 86 reports, in the reporter's own words as published by the FDA.

• DeathApr 20, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY IN THEIR SLEEP. THE FAMILY MEMBERS OF THE PATIENT FELT THAT THE IMPLANTABLE PULSE GENERATOR (IPG) MALFUNCTIONED AND WERE QUESTIONING THE PACEMAKER FUNCTION. ADDITIONAL INFORMATION RELATED TO THE CAUSE OF THEIR DEATH WAS NOT AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24925698 ↗
• InjurySep 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE IPG SYSTEM WAS EXPLANTED DUE TO METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS BACTEREMIA. VEGETATION WAS NOTED ON THE RV LEAD. THE PATIENT DEVELOPED MRSA PNEUMONIA AND CULTURES CONFIRMED MRSA. ANTIBIOTICS WERE ADMINISTERED AND A NEW LEADLESS IPG WAS PLACED.

  Patient problems: Drug Resistant Bacterial Infection; No Clinical Signs, Symptoms or Conditions; Pneumonia

  MAUDE report 23049442 ↗
• InjurySep 3, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA WITH HEART RATES IN THE FORTIES. THE PATIENT WORE A HOLTER MONITOR AND IT SHOWED THERE WAS T-WAVE OVERSENSING (TWOS) ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD AND IPG REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22951051 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION AND POCKET PAIN. THE IMPLANTABLE PULSE GENERATOR (IPG) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21678029 ↗
• InjuryJan 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN BACTEREMIA INFECTION IN THE POCKET AND DISCOMFORT. 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; Discomfort

  MAUDE report 21189257 ↗
• MalfunctionJan 8, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT BY THE PATIENT'S REPRESENTATIVE THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A POSSIBLE TELEMETRY ISSUE. 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 21100981 ↗
• InjurySep 26, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED UNSTABLE THRESHOLDS. IT WAS ALSO REPORTED THAT THE UNSTABLE RV THRESHOLDS LEAD TO PREMATURE BATTERY DEPLETION OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE RV HIS BUNDLE LEAD WAS CAPPED AND REPLACED 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 20310633 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED 'WEIRD TWITCHING MOVEMENTS'. THE PATIENT WAS HOSPITALIZED. THE IMPLANTABLE PULSE GENERA TOR (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

  MAUDE report 20074056 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. THE PATIENT WAS TEMPORARILY PACED UNTIL THE INFECTION CLEARED.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19189821 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED ENTEROCOCCUS FAECALIS BACTEREMIA, ENDOCARDITIS AND A FEVER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Endocarditis; Fever; Unspecified Infection

  MAUDE report 19132462 ↗
• MalfunctionApr 5, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN AND BRADYCARDIA. IT WAS FURTHER REPORTED THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE LOWER RATE. THE IPG SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Abdominal Pain; Bradycardia

  MAUDE report 19049968 ↗
• DeathJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CARDIAC ARREST, HEART BLOCK AND ASYSTOLE POST TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED HOWEVER THE ATRIAL LEAD WAS UNABLE TO BE PLACED DUE TO ATRIALSTANDSTILL. THE IPG IMPLANT WAS SUCCESSFUL. THE PATIENT LATER DIED POST IMPLANT, HOWEVER THE PHYSICIAN REPORTED THEIR DEATH WAS NOT RELATED TO THEIR IPG OR THE IPG IMPLANT PROCEDURE.

  Patient problems: Asystole; Cardiac Arrest; Heart Block

  MAUDE report 18612409 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSTABLE VENTRICULAR TACHYCARDIA (VT) DURING A SURESCAN OPERATION. A CARDIOVERSION WAS PERFORMED. THE PATIENT WAS ADMINISTERED MEDICATION AND WAS TRANSFERRED TO THE EMERGENCY ROOM FOR MONITORING. 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 18474353 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. IT WAS NOTED THE INFECTION WAS NOT DUE TO THE DEVICE SYSTEM, HOWEVER, THERE IS NO INFORMATION REGARDING THE SOURCE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18346901 ↗
• MalfunctionNov 15, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE HAVING TROUBLE SENDING A REMOTE TRANSMISSION. THE IMPLANTABLE PULSE GENERATOR (IPG) AND REMOTE MONITOR EXHIBITED NO TELEMETRY. PLACED READER DIRECTLY ON THE SKIN AND REQUESTED TO MAKE TRANSMISSION PLACING THE READER OVER THE SHIRT. ASKED ABOUT THE SETUP AND IT WAS FINE. PATIENT DOES NOT HAVE ELECTRIC DEVICES NEAR THE MONITOR. IT WAS REQUESTED TO MAKE AN APPOINTMENT WITH THE PHYSICIAN IN ORDER TO INTERROGATE THE DEVICE AND TO TAKE BEDSIDE MONITOR TO THE APPOINTMENT. THE IPG REMAINS IN USE. THE REMOTE MONITOR 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 18139212 ↗
• MalfunctionJun 13, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) TRANSMISSION COULD NOT BE SENT. 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 17118203 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET EROSION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 16544644 ↗
• DeathOct 24, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT FOLLOWING AN MAGNETIC RESONANCE IMAGING (MRI) THE IMPLANTABLE PULSE GENERATOR ( IPG) "WAS NOT TURNED BACK ON" AND AS A RESULT THE PATIENT DIED.  IT WAS ALSO REPORTED THE DECEDENT WAS STILL IN THEIR VEHICLE IN THE DRIVEWAY OF THEIR RESIDENCE AFTER HAVING HAD THE MRI WHEN THEY WENT INTO A LETHAL ARRHYTHMIA LEADING TO DEATH. THE DECEDENTS RHYTHM WHILE IN THE CARE OF THE FIRST RESPONDERS REQUIRED EXTERNAL DEFIBRILLATION.  THE (IPG) WAS REMOVED.

  Patient problems: Arrhythmia; Tachycardia

  MAUDE report 15658346 ↗
• InjuryAug 29, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND IMPEDANCES. THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. THE RA LEAD AND IPG WERE 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 15315779 ↗
• MalfunctionAug 12, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE AV MODE THRESHOLD WAS COMPROMISED. THE IMPLANTABLE PULSE GENERATOR (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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15216355 ↗
• InjuryJul 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, APPROXIMATELY EIGHT MONTHS POST IMPLANT, THE PATIENT EXPERIENCED AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM RELATED INFECTION. THE SINGLE CHAMBER 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 15090646 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE POCKET SITE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 14797088 ↗
• InjuryMay 12, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE TEMPORARY-PERMANENT IMPLANTABLE PULSE GENERATOR (IPG) WAS NO LONGER FUNCTIONING. THE IPG WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14367220 ↗
• InjuryApr 28, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED DUE TO A POTENTIAL PERFORMANCE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240785 ↗
• MalfunctionMar 2, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY FELT THE SAME WAY AS THEY DID PRIOR TO BEING IMPLANTED, AND THOUGHT THEIR IMPLANTABLE PULSE GENERATOR (IPG) "ISN'T WORKING".  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

  MAUDE report 13652343 ↗

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-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-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-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-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-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.