Advisa DR MRI™ SureScan® A2DR01 (UDI 00643169493377)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,298 adverse event reports that list this exact device (DI 00643169493377), received between Dec 9, 2016 and Sep 30, 2026 — classified as 51 deaths, 1,260 injuries, 987 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (436 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 2,298 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Pacing Problem

  It was reported that atrial events were  falling in blanking period. Observed device classified termination of AT/AF detected events and inappropriate atrial pacing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944120 ↗
• InjurySep 28, 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 50917596 ↗
• MalfunctionSep 28, 2026Pacing Problem

  It was reported that atrial events were falling in blanking period. Observed device classified termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) detected events resulting in inappropriate atrial pacing. 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 50913470 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a pocket infection and erosion. A skin ulcer was noted at the pocket site. 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; Pocket Erosion; Ulcer

  MAUDE report 50866830 ↗
• InjurySep 7, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50647315 ↗
• MalfunctionSep 4, 2026Pacing Problem

  It was further reported that the IPG did not exhibit a performance issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611223 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection. The Implantable Pulse Generator (IPG) system was explanted with no replacement. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50516520 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a pocket infection. The Implantable Pulse Generator (IPG) was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection

  MAUDE report 50403577 ↗
• MalfunctionAug 24, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50402050 ↗
• MalfunctionAug 20, 2026Pacing Problem

  It was reported that the patient experienced feeling "weak". It was further noted that the Implantable Pulse Generator (IPG) exhibited "firing". The IPG remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 50347118 ↗
• MalfunctionAug 14, 2026Electromagnetic Interference; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252567 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient stated that "lost consciousness this morning". 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 50232976 ↗
• MalfunctionAug 12, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50226212 ↗
• MalfunctionAug 12, 2026Incorrect Measurement

  It was reported that the Implantable Pulse Generator's (IPG) battery estimate went from three months in February to six months in July. 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 50220483 ↗
• MalfunctionAug 10, 2026Pacing Problem

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) AF stored episodes resulting in termination of AT/AF detected event(s) in progress, with inappropriate pacing noted at times. It was also reported that atrial events were falling in blanking period resulting in inappropriate pacing at times. The Implantable Pulse Generator (IPG) and RA 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 50190064 ↗
• InjuryAug 10, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the patient experienced pacing induced cardiomyopathy resulting in drop in ejection fraction. The Implantable P ulse Generator (IPG) was explanted and replaced with a Cardiac Resynchronization Therapy Pacemaker (CRT-P) system. 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 50189597 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced bacteremia. The organism of the infection was identified to be Staphylococcus aureus. T he Implantable Pulse Generator (IPG) system was removed. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 50139898 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection and experienced discomfort, bacteremia and endocarditis. The system was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Discomfort; Endocarditis; Unspecified Infection

  MAUDE report 50065715 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced sepsis post implant of a Right Ventricular (RV) lead. It was also reported that RV lead subsequently exhibited fracture and noise. The patient reported symptoms of dizziness, flutter and hiccups at the time the lead was diagnosed as fractured. The RV lead was explanted and replaced. The Implantable Pulse Generator (IPG) implanted at the time of alleged sepsis was subsequently explanted and replaced. The Right Atrial (RA) lead implanted at the time of the alleged sepsis remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Sepsis

  MAUDE report 50053366 ↗
• DeathJul 21, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT REPRESENTATIVE THAT THEY WERE ATTEMPTING TO GET A NEW IMPLANTABLE PULSE GENERATOR (IPG) AND THE OLD DEVICE CAUSED THE PATIENT DEATH.

  Patient problems: Insufficient Information

  MAUDE report 25889154 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 25778324 ↗
• MalfunctionJul 9, 2026Pacing Problem

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

  Patient problems: Bradycardia; Fatigue

  MAUDE report 25759300 ↗
• InjuryJun 11, 2026Device Sensing Problem

  IT WAS REPORTED THAT EXPERIENCED A SEIZURE LIKE SYMPTOMS AND WAS "SHAKING." IT WAS REPORTED THAT THE PATIENT WAS IN TORSADES HEART RHYTHM. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD BOTH EXHIBITED UNDER SENSING. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS AT RECOMMENDED REPLACEMENT TIME (RRT) AND WAS NOT DETECTING ARRYTHMIAS. THE RV LEAD WAS REPROGRAMMED AND AT A LATER DAY THE SYSTEM WAS PROGRAMMED OFF. A NEW SYSTEM WAS PLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Convulsion/Seizure

  MAUDE report 25468469 ↗
• MalfunctionJun 10, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A 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 25454404 ↗
• InjuryJun 4, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE AFTER THE PATIENT WAS PROGRAMMED TO AN MAGNETIC RESONANCE IMAGING (MRI) SAFE MODE, THE PATIENT EXPERIENCED DISCOMFORT, AN ELEVATED HEART RATE, DID NOT FEEL WELL, AND FELT "FLUSHED". THE PATIENT WAS HOSPITALIZED AND REPROGRAMMED OUT OF THE MRI SAFE MODE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 25390852 ↗

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