Azure™ S DR MRI SureScan™ W3DR01 (UDI 00643169871922)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00643169871922), received between Apr 10, 2018 and Sep 8, 2025 — classified as 22 injuries, 20 malfunctions.

The most frequently reported specific device problem is “False Alarm” (5 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2025False Alarm; False Alarm

  IT WAS REPORTED THAT THE DEVICE EXHIBITED FALSE LOW IMPEDANCE WARNING FOR THE RIGHT ATRIAL (RA) LEAD. 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 22992754 ↗
• MalfunctionMay 29, 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 22103201 ↗
• MalfunctionOct 17, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE FEELING PRE SYNCOPAL DURING EXERCISE THAT WAS SIMILAR TO WHEN THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Presyncope

  MAUDE report 20469541 ↗
• MalfunctionOct 4, 2024False Alarm; False Alarm

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS. ON INTERROGATION IT WAS FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POTENTIAL OVERSENSING. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE RIGHT ATRIAL (RA) LEAD LOW IMPEDANCE WARNING. THE RV LEAD AND THE IPG REMAIN 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 20366438 ↗
• MalfunctionMay 3, 2024Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED POSSIBLE ELECTROMAGNETIC INTERFERENCE (EMI) POTENTIALLY CAUSING NOISE/ARTIFACT ON THE LEADS. THE LEAD 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 19237529 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY THREE WEEKS POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM THE PATIENT DEVELOPED AN INFECTION. CULTURES WERE TAKEN AND THE ORGANISM WAS IDENTIFIED AS BACTEREMIA. THE IPG SYSTEM WAS EXPLANTED AND REPLACED BY A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 17143242 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 17077415 ↗
• InjuryDec 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY ONE WEEK POST IMPLANT THAT THE PATIENT DEVELOPED 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 16041366 ↗
• MalfunctionSep 22, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED UNEXPECTED BATTERY DRAIN 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 15468748 ↗
• MalfunctionJun 22, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A CHANGE IN PACING AND PROLONGED QRS COMPLEX. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE, TRIGGERING A WARNING. THE IPG, RV LEAD AND RA 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 14780823 ↗
• InjuryDec 14, 2021Appropriate 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 UNKNOWN REASONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12997712 ↗
• InjuryDec 7, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NO CAPTURE , FAR FIELD R-WAVE (FFRW) OVERSENSING, UNDERSENSING AND WAS NOT SENSING ATRIAL ACTIVITY ON CURRENT ELECTROGRAMS (EGM). IT WAS ALSO REPORTED THAT THE RA LEAD HAD DISLODGED ACCORDING TO X-RAY AND THE PHYSICIAN. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. THE RA 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 12957178 ↗
• InjuryMar 11, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT THAT THEIR DEVICE WILL FLIP UP AND CAUSE PAIN AT THE POCKET SITE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS MOVED SUBMUSCULAR BY THE PHYSICIAN TO PREVENT PAIN. IT WAS FURTHER REPORTED THAT POST MOVING THE DEVICE SUBCUTANEOUS TO SUBMUSCULAR BUT PRIOR TO THE POCKET BEING CLOSED THE RIGHT ATRIAL (RA) LEAD EXHIBITED DISLODGEMENT AND HIGH THRESHOLDS. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RA AND RV LEADS WERE EXPLANTED AND REPLACED AND THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 11459469 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET EROSION, THE DEVICE ERODED THROUGH THE SKIN AT THE POCKET. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED. DRAIN WAS USED AND A FEW DAYS LATER A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 11017286 ↗
• InjuryNov 23, 2020Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE, ARRHYTHMIA, HEART BLOCK, BRADYCARDIA WHICH REQUIRED TRANSCUTANEOUS PACING AND WAS ADMITTED TO HOSPITAL. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE, HIGH THRESHOLDS AND ELEVATED THRESHOLD. THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PACING ISSUE. THE RV WAS REPROGRAMMED AND REMAINS IN USE. THE IPG REMAINS IN USE. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED SEVERE METABOLIC ISSUES WHICH WAS CONTRIBUTING TO THE LOSS OF CAPTURE AND THE CONDITION OF THE PATIENT. ONCE THESE ISSUES WERE NORMALIZED, CAPTURE WAS AGAIN ABLE TO BE OBTAINED. THE PATIENT HAS SINCE PASSED AWAY WITH NO ALLEGATION TO IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM.

  Patient problems: Arrhythmia; Bradycardia; Heart Block; Syncope/Fainting

  MAUDE report 10886260 ↗
• MalfunctionJul 29, 2020Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY DON'T FEEL WELL FOLLOWING AN UNRELATED MEDICAL PROCEDURE IN WHICH THEY WERE EXPOSED TO A MAGNET. THEY ARE CONCERNED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) MAY NOT BE PACING "RIGHT". THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 10336967 ↗
• InjuryMar 20, 2020Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED TACHYCARDIA AND SYNCOPE. A POSSIBLE PACING FAILURE WAS ALSO REPORTED. IT WAS NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PERFORMING AS PROGRAMMED. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope; Tachycardia

  MAUDE report 9858890 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED AS IT "DID NOT FIT." THE IPG WAS UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9829486 ↗
• MalfunctionJan 9, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THERE WAS AN INCORRECT BATTERY VOLTAGE MEASUREMENT 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 Known Impact Or Consequence To Patient

  MAUDE report 9569655 ↗
• InjurySep 23, 2019Reset Problem; Data Problem; Reset Problem; Data Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) UNDERWENT A DIAGNOSTIC RESET AND CONSEQUENTLY BATTERY VOLTAGE DATA WAS UNAVAILABLE. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9102557 ↗
• MalfunctionSep 19, 2019Reset Problem; Reset Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE INDICATED THAT A POWER ON RESET (POR) OCCURRED. THE DEVICE REMAINS IN USE. THIS EVENT WAS NOT REPORTED BY A HEALTH CARE PROVIDER; THEREFORE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9088110 ↗
• MalfunctionAug 12, 2019Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) DISPLAYED A FALSE WARNING FOR ATRIAL LOW UNIPOLAR IMPEDANCE. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8883393 ↗
• InjuryJul 31, 2019Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD AN ELECTRICAL RESET. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8844922 ↗
• MalfunctionJul 4, 2019Incorrect Measurement; Protective Measures Problem; Incorrect Measurement; Protective Measures Problem

  IT WAS REPORTED THAT A FALSE ATRIAL LEAD LOW IMPEDANCE WARNING OCCURRED ON THE IMPLANTABLE PULSE GENERATOR (IPG). THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8762550 ↗
• InjuryMay 31, 2019Adverse 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 EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8658638 ↗

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-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-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• 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-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-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-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.