Azure™ XT SR MRI SureScan™ W1SR01 (UDI 00643169634626)Recalls & reported problems

Summary

The FDA's MAUDE database contains 425 adverse event reports that list this exact device (DI 00643169634626), received between Jun 5, 2018 and Aug 5, 2026 — classified as 11 deaths, 242 injuries, 172 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (68 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 425 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Adverse 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 with a Leadless implantable pulse generator (IPG). No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50139824 ↗
• InjuryJul 29, 2026Pacing Problem

  It was reported that the Right Atrial (RA) lead, which is place in the right ventricle port, exhibited a possible sensing issue on presenting electrograms (EGM) and short v-v intervals. The RA lead remains un use. It was further reported that the lead exhibited intermittent undersensing on current electrograms (EGM) with false classification/te rmination of ongoing arrhythmias. It was further reported that the patient experienced sinus pause for two minutes with a heart rate in the fifties. Gaps were also observed between the QRS on External Cardiac Monitor. The RA lead exhibited undersensing of Atrial Fibrillation (AF) waves noted resulting in unnecessary pacing at times. The Implantable Pulse Generator (IPG) remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Non specific EKG/ECG Changes

  MAUDE report 50077333 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25076875 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACTEREMIA DUE TO ENTEROCOCCUS FAECALIS. 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: Bacteremia

  MAUDE report 24442879 ↗
• MalfunctionJan 26, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE REMOTE MONITORING MOBILE APPLICATION GENERATED A MESSAGE INDICATING THAT IT WAS SEARCHING FOR THE PATIENT CONNECTOR WHEN THE CONNECTOR WAS PLACED ON THE PATIENT¿S CHEST. IT WAS NOTED THAT BLUETOOTH STATUS ON THE CONNECTOR APPEARED CONNECTED, WITH THE POWER INDICATOR SOLID GREEN, THE BLUETOOTH INDICATOR SOLID BLUE, AND THE STATUS INDICATOR BLINKING YELLOW. IT WAS FURTHER NOTED THAT ATTEMPTS TO INTERROGATE THE IMPLANTABLE PULSE GENERATOR (IPG) RESULTED IN A ¿NO DEVICE FOUND¿ MESSAGE. BLUETOOTH ON THE IMPLANTABLE PULSE GENERATOR (IPG) WAS CONFIRMED TO BE ACTIVE, INDICATED BY A BLUE LIGHT. WHEN ATTEMPTING TO LOCATE THE DEVICE, THE CONNECTOR BLINKED ORANGE AND DISPLAYED AN ¿UNABLE TO FIND DEVICE¿ MESSAGE. THE CONNECTION ATTEMPT WAS UNSUCCESSFUL DESPITE THE MODEL BEING POWERED ON AND WITHIN RANGE. TROUBLESHOOTING STEPS WERE TAKEN TO INCLUDE CONFIRMING BLUETOOTH WAS ENABLED ON THE HOST TABLET AND THAT WIRELESS FIDELITY WAS CONNECTED, POWER CYCLING THE HOST TABLET, AND CONFIRMING BOTH THE HOST TABLET AND PATIENT CONNECTOR WERE CONNECTED TO EXTERNAL POWER. THE ISSUE PERSISTED FOLLOWING THESE STEPS. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO PATIENT COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24175966 ↗
• MalfunctionJan 16, 2026Pacing Problem

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

  Patient problems: Bradycardia

  MAUDE report 24091920 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, PURULENT DISCHARGE, REDNESS AND SWELLING DUE TO AN INFECTION. THE ORGANISM WAS NOT IDENTIFIED. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 23642274 ↗
• MalfunctionSep 18, 2025Failure to Interrogate; Appropriate Device Problem Term/Code Not Available; Failure to Interrogate; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT DEVICE STOPPED WORKING. THE IMPLANTABLE PULSE GENERATOR (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 23082248 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED VEGETATION ON THE TRICUSPID VALVE DUE TO A BACTEREMIA INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED WITHOUT REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Medical device site infection; Unspecified Infection

  MAUDE report 23014576 ↗
• MalfunctionAug 26, 2025False Alarm; False 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 22892534 ↗
• MalfunctionAug 18, 2025Pacing Problem; Pacing Problem

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

  Patient problems: Bradycardia

  MAUDE report 22826098 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. VEGETATION AND SEPSIS WERE ALSO OBSERVED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; Sepsis

  MAUDE report 21854632 ↗
• MalfunctionMar 18, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PACING BELOW THE LOWER RATE. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER SENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS AT TIMES AND DIMINISHED SENSING. BOTH THE IPG AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21629210 ↗
• MalfunctionMar 14, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ELEVATED HEART RATE. UPON INTERROGATION, IT WAS FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE RV LEAD WAS REPROGRAMMED. IT WAS FOUND THAT THE RV LEAD EXHIBITED OCCASIONAL UNDERSENSED BEATS. WHEN THE RV LEAD WAS INTERROGATED ON A LATER DATE, NO FURTHER RV UNDERSENSING WAS NOTED. THE RV LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL STUDY. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED ABNORMAL BATTERY DEPLETION. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604842 ↗
• MalfunctionMar 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH. THE PATIENT ALSO SUSPECTED THEIR DEVICE "WASN'T WORKING. "THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 21544693 ↗
• InjuryFeb 7, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED EARLY BATTERY DEPLETION. THE IPG WAS EXPLANTED AND REPLACED. THE EAD 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 21331145 ↗
• MalfunctionDec 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED "A LOT OF PROBLEMS" AND DID NOT THINK IMPLANTABLE PULSE GENERATOR (IPG) "WAS WORKING". 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 20890989 ↗
• InjuryDec 2, 2024Premature Discharge of Battery; Pacing Problem; Premature Discharge of Battery; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20817835 ↗
• DeathNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS FOUND FACE DOWN IN THE BATHROOM AND HAD PASSED AWAY. THERE WAS AN ALLEGATION THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RELATED TO THE PATIENTS DEATH.

  Patient problems: Insufficient Information

  MAUDE report 20771798 ↗
• MalfunctionNov 22, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING AT LOWER RATES. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 20756657 ↗
• MalfunctionNov 20, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE LOWER RATE. THE IMPLANTABLE PULSE GENERATOR (IPG) 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 20733106 ↗
• InjuryOct 21, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWIDDLER SYNDROME. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS OUT OF THE POCKET AND TAPED TO THE CHEST. THE 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: Twiddlers Syndrome

  MAUDE report 20493469 ↗
• MalfunctionOct 21, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED HEART RATE "IN HIGHER RATE BINS 110-185BPM". THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Tachycardia

  MAUDE report 20491045 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 20298783 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED SYNCOPAL EPISODES. THE RA LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Dizziness; Heart Block; Muscle Weakness/Atrophy; Obstruction/Occlusion; Syncope/Fainting

  MAUDE report 20040630 ↗

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-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-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-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-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-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-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.