Advisa DR MRI™ SureScan® A2DR01 (UDI 00613994713650)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,758 adverse event reports that list this exact device (DI 00613994713650), received between Dec 9, 2013 and Sep 29, 2026 — classified as 41 deaths, 949 injuries, 768 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (326 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,758 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Pacing Problem

  The patient reported that after an Magnetic Resonance Imaging (MRI) they felt unwell. They reported that during the MRI there heart was pounding, then after they experienced lightheaded-ness, dizziness, fatigue and heart rates in the forties. The Implantable Pulse Generator (IPG) remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Dizziness; Fatigue; Palpitations

  MAUDE report 50932243 ↗
• MalfunctionSep 24, 2026Pacing Problem

  It was reported that the patient experienced weakness and the Implantable Pulse Generator (IPG) was pacing below the lower set rate. 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 50883354 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Endocarditis

  MAUDE report 50751043 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient felt the pacing and pulsing in their neck and it wakes them up at night. It was also reported that the Right Ventricular (RV) lead exhibited steadily increasing impedance resulting in high impedance causing them to be unable to have Magnetic Resonance Imaging (MRI) scan. Both the Implantable Pulse Generator (IPG) and the RV lead remains in use. No further patient complications have been reported as a result of this event. It was further reported that the RV lead exhibited polarity switch. The RV lead was reprogrammed and the IPG was explanted and replaced.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50688933 ↗
• InjurySep 1, 2026Electrical /Electronic Property Problem

  Patient problems: Chest Pain

  MAUDE report 50542949 ↗
• MalfunctionAug 12, 2026Pacing Problem

  Patient problems: Bradycardia

  MAUDE report 50222462 ↗
• MalfunctionAug 10, 2026Pacing Problem

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds. It was also stated that  "Looked like device wasn't pacing correctly on telemetry". Both the RV lead and 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 50192839 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain at the site of the implant, the Implantable Pulse Generator (IPG) also reached Elective Replacement Indicator (ERI). The IPG was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Pain

  MAUDE report 50170061 ↗
• InjuryJul 29, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that Implantable Pulse Generator (IPG) was non-Prophylactically replaced. 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 50077620 ↗
• MalfunctionJul 9, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25763014 ↗
• MalfunctionJul 2, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. THE HEART RATE WAS PACING BELOW THE LOWER RATE LIMIT. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER-SENSING ON STORED ELECTROGRAMS (EGM) DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS AND MISCLASSIFICATION OF EPISODE TYPES. THE IMPLANTABLE PULSE GENERATOR (IPG) AND RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 25687954 ↗
• InjuryMay 12, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT ATTENDED THE EMERGENCY ROOM AS THEY EXPERIENCED SYNCOPE. UPON DEVICE ASSESSMENT IT WAS NOTED THAT T HE IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE RIGHT ATRIAL (RA) LEAD WAS ALSO UNDER SENSING, DURING ATRIAL TACHYCARDIA (AT)/AF STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. THE IPG AND RA LEAD BOTH REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25148081 ↗
• MalfunctionApr 28, 2026Device Sensing Problem

  IT WAS REPORTED THAT DURING INTERROGATION MIRROR IMAGE ARTIFACT WAS NOTED IN A FEW EPISODES AND INTERMITTENTLY. SENSING ISSUES, SPECIFICALLY NOISE, WERE IDENTIFIED ON BOTH THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD. ADDITIONALLY, A NON-PHYSIOLOGIC SENSING WAS IDENTIFIED ON THE RV AND RA LEAD. DEVICE INTERROGATION WAS PERFORMED, AND REPROGRAMMING WAS CONDUCTED AS AN INTERVENTION. THE RA AND RV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A DETECTION/SENSING ISSUE. THE RA LEAD AND THE RV LEAD EXHIBITED INSULATION BREACH. THE IPG SYSTEM REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25014825 ↗
• MalfunctionApr 28, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT REPRESENTATIVE THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) "MIGHT NOT BE WORKING" AND THE PATIENT'S BLOOD PRESSURE HAS BEEN FLUCTUATING. 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 25012304 ↗
• MalfunctionApr 24, 2026False Alarm

  IT WAS REPORTED THAT THERE WAS A FALSE LEAD IMPEDANCE ON THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS ALSO NOTED THERE WAS AN OUT OF RANGE (OOR) LEAD IMPEDANCE ON THE RIGHT ATRIAL (RA) LEAD. IT WAS ALSO NOTED THERE WAS A POLARITY SWITCH AND THERE WERE HIGH SHORT V-V INTERVALS ON THE SENSING INTEGRITY COUNTER (SIC) AND NOISE. THE IPG SYSTEMA REMAINS USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24979486 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND EXPERIENCED PURULENT DISCHARGE. 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 24977274 ↗
• MalfunctionApr 22, 2026Unable to Obtain Readings; Communication or Transmission Problem

  IT WAS FURTHER REPORTED THAT THERE WAS A HIGH COUNT OF POLARIZATION IGNORES. IT WAS FURTHER NOTED THAT TELEMETRY INTERFERENCE MAY HAVE BEEN A CONTRIBUTING FACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953463 ↗
• MalfunctionApr 17, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS TELEMETRY ISSUE AND THE RIGHT ATRIAL (RA) LEAD HAD A LOSS OF CAPTURE. THE RA LEAD AND 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 24912043 ↗
• InjuryApr 15, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS WHEN WALKING, UPON INTERROGATION, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD ATRIAL LEAD HAD A POLARITY SWITCH DUE TO LOW IMPEDANCE MEASUREMENTS, NOISE AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED SHORT V-V, AND NOISE. THE DEVICE WAS INITIALLY REPROGRAMMED TO MINIMIZE NOISE EPISODES CAUSING PACING INHIBITION. THE LEADS WERE THEN CAPPED AND THE IMPLANTABLE PULSE GENERATOR (IPG) EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 24884235 ↗
• MalfunctionApr 14, 2026Failure to Interrogate

  IT WAS REPORTED THAT A PATIENT WITH AN IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED A FAILED TELEMETRY TRANSMISSION USING THE MYCARELINK MONITOR WHEN ATTEMPTING TO INITIATE A TRANSMISSION BY PLACING THE MONITOR OVER THE DEVICE. THE PATIENT STATED THE TELEMETRY PROCESS DID NOT START, THE MONITOR REPEATEDLY RETURNED TO THE START SCREEN, AND NO PROGRESS BAR APPEARED DURING MULTIPLE ATTEMPTS. THE PATIENT ADJUSTED THE MONITOR POSITION SEVERAL TIMES, CORRECT MONITOR PLACEMENT WAS VERIFIED, AND THE PATIENT CONFIRMED THERE WAS NO NEARBY EQUIPMENT THAT COULD INTERFERE WITH THE SIGNAL. NO SUCCESSFUL TELEMETRY TRANSMISSION OCCURRED, THE PATIENT WAS NOT CONNECTED TO THE DEVICE, AND THE PATIENT WAS REFERRED TO A DOCTOR¿S OFFICE/CLINIC FOR AN IN-PERSON DEVICE CHECK. 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 24869405 ↗
• MalfunctionApr 10, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THERE WAS A TELEMETRY ISSUE WITH THE IMPLANTABLE PULSE GENERATOR (IPG) WITH NO SUCCESSFUL TRANSMISSIONS.THE SMART MONITORING APPLICATION WAS UNABLE TO SEND A MANUAL TRANSMISSION, WITH THE PROGRESS BAR STOPPING DURING TELEMETRY AND MULTIPLE UNSUCCESSFUL DATA TRANSMISSION ATTEMPTS DESPITE TROUBLESHOOTING STEPS. THE PATIENT DID NOT HAVE A GOOGLE PIXEL OR ZTE SMARTPHONE, THE READER BATTERIES WERE REPLACED, A DRY WASHCLOTH WAS PLACED BETWEEN THE READER AND THE IMPLANT, AND THE PATIENT CONFIRMED THERE WERE NO INTERFERENCE DEVICES NEARBY. THE READER BATTERIES WERE REMOVED AND REINSERTED, BUT THE PROGRESS BAR CONTINUED TO STOP DURING TELEMETRY AND NO ERROR CODE APPEARED ON THE APPLICATION. THE PATIENT WAS REFERRED TO THEIR CLINIC AND ADVISED TO TAKE THE MONITOR TO THE APPOINTMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838801 ↗
• MalfunctionApr 9, 2026Pacing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PREMATURE VENTRICULAR CONTRACTIONS (PVC) AND BIGEMINY AS THE IPG WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI).

  Patient problems: Arrhythmia; Bradycardia

  MAUDE report 24830118 ↗
• MalfunctionApr 1, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THERE WAS NO PERFORMANCE ISSUE WITH THE IPG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754114 ↗
• MalfunctionMar 31, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY HAVE BEEN "FEELING SHITTY" AND THERE IS A " PROBLEM 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: Insufficient Information

  MAUDE report 24742366 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT THE PATIENT EXPERIENCED AN INFECTION ONE MONTH POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. THE IPG SYSTEM WAS REMOVED AND LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24700466 ↗

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-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-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• Z-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• 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-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 (e) Mo
• 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 Number
• 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.