Azure™ S SR MRI SureScan™ W3SR01 (UDI 00763000316716)Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00763000316716), received between May 7, 2021 and Sep 29, 2026 — classified as 5 deaths, 54 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (11 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 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Interrogate

  It was reported by the patient that they had trouble "hooking up the device for transmitting". 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 50933106 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection. and experienced redness. 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: Erythema; Unspecified Infection

  MAUDE report 50537844 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a Staphylococcus aureus bacterial infection approximately one month post Implantable Pulse Generator (IPG) implant with resulting erythema and bacteremia. The IPG system was explanted and replaced with a Leadless implantable pulse generator (IPG). No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Bacterial Infection; Erythema

  MAUDE report 50127877 ↗
• MalfunctionMay 5, 2026False Alarm

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE IMPEDANCE WARNING. THE IPG AND 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 25080671 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION. THE ORGANISM WAS IDENTIFIED AS METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS. THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE RIGHT ATRIAL (RA) LEAD WERE EXPLANTED WITHOUT REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 24830402 ↗
• InjuryFeb 25, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE 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 24442919 ↗
• InjuryJan 9, 2026Pacing Problem

  IT WAS NOTED THAT THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Discomfort; Dyspnea

  MAUDE report 24020088 ↗
• DeathJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT PASSED AWAY ONE DAY POST EXPLANT.

  Patient problems: Fluid Discharge; Pocket Erosion; Unspecified Infection

  MAUDE report 24019733 ↗
• MalfunctionDec 19, 2025False Alarm; False Alarm

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED FALSE RIGHT VENTRICULAR (RV) LEAD LOW IMPEDANCE ALERT. 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 23848428 ↗
• InjuryNov 17, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566394 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION IN THE PACEMAKER POCKET ALONG WITH PURULENT DISCHARGE/PUS AND REDNESS. IT WAS NOTED THAT THE ORGANISM OF INFECTION WAS STAPHYLOCOCCUS AUREUS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Erythema; Medical device site infection; Purulent Discharge

  MAUDE report 23355712 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEPSIS DUE TO A BACTEREMIA INFECTION. THE ORGANISM WAS IDENTIFIED AS E. COLI. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Sepsis; Unspecified Infection

  MAUDE report 23278936 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH FEVER AND THERE WAS REDNESS ALSO. THE PATIENT WAS IN DISCOMFORT AS WELL. IT WAS ALSO REPORTED THAT THE PATIENT HAD AN INFECTION AND THE ORGANISM WAS CANDIDA AURIS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Fever; Fungal Infection

  MAUDE report 23084369 ↗
• MalfunctionSep 12, 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 23036975 ↗
• InjurySep 4, 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. IT WAS NOTED THE PATIENT EXPERIENCED DISCOMFORT, EROSION AND REDNESS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED WITH A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Erythema; Unspecified Infection

  MAUDE report 22966753 ↗
• MalfunctionAug 22, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) APPEARS TO HAVE BEEN SET TO EMERGENCY VVI PROGRAMMING FOLLOWING AN MAGNETIC RESONANCE IMAGING (MRI) SCAN. 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 22872875 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FIVE WEEKS POST IMPLANT THE PATIENT EXPERIENCED AN INFECTION AT THE PACEMAKER INCISION SITE. THE ORGANISM OF THE INFECTION WAS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. THE PATIENT ALSO EXPERIENCED DISCOMFORT, FEVER, REDNESS AND SEPSIS/SEPTICEMIA. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Drug Resistant Bacterial Infection; Erythema; Fever; Sepsis; Unspecified Infection

  MAUDE report 22826803 ↗
• MalfunctionAug 11, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THE PHYSICIAN NOTED THAT THE "SCREW WAS BROKEN AND THE PIN PLUG COULD NOT BE REMOVED". THE IMPLANTABLE PULSE GENERATOR (IPG) AND PACING LEAD WAS ATTEMPTED/ NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768772 ↗
• MalfunctionAug 1, 2025Positioning Failure; Mechanical Problem; Misconnection; Pacing Problem; Connection Problem; Positioning Failure; Mechanical Problem; Misconnection; Pacing Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A CONNECTOR ISSUE. IT WAS NOTED THAT THERE WAS DIFFICULTY INSERTING THE LEAD PIN INTO THE CONNECTOR PORT. THE PACING LEADS WERE UNABLE TO BE FULLY SEATED INTO THE HEADER. THE PACING LEADS WERE REATTEMPTED AND WERE ABLE TO BE SEATED IN THE HEADER, HOWEVER INCONSISTENT PACING WAS NOTED. IT WAS FURTHER REPORTED THAT THE PACING LEADS EXHIBITED A HELIX EXTENSION/RETRACTION ISSUE. THE HELIX OF THE PACING LEADS WOULD NOT EXTEND. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS ATTEMPTED/NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22685056 ↗
• InjuryJul 31, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT AFTER THE PLACEMENT OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), PHYSICIAN NOTED FIVE SECONDS OF ASYSTOLE. A TEMPORARY PACEMAKER WAS PLACED. AFTER THAT, ANOTHER THREE TO FOUR EPISODES OF ASYSTOLE FOR TWO SECONDS LASTED. TEMPORARY LOSS OF CAPTURE WAS NOTED ON BOTH LEADLESS IPG AND THE TRANSVENOUS IPG. THEREFORE, BOTH SYSTEMS REMAIN IMPLANTED WITH THE LEADLESS IPG AS BACKUP PACING SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole

  MAUDE report 22676566 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS NOTED TO BE PROTRUDING THROUGH SKIN. THE IPG SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22437200 ↗
• InjuryMay 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 INFECTION APPROXIMATELY THREE WEEKS POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. THE SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22055024 ↗
• InjuryMar 10, 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. PURULENT DISCHARGE/ PUS WAS ALSO OBSERVED. THE IPG SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 21557863 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION. IT WAS ALSO REPORTED THAT THE SITE HAD SWELLING, REDNESS, TENDERNESS AND PAIN. THERE WAS ALSO RIGHT SHOULDER SWELLING AND TENDERNESS AND COULD NOT MOVE DUE TO POSSIBLE SEPTIC ARTHRITIS PARTICULARLY IN THE PLACE OF THE PACEMAKER. IT WAS NOTED THAT THE INFECTION COULD BE SEEDED AS PATIENT HAD SEVERAL INJECTIONS. BLOOD CULTURES WERE NEGATIVE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED. A DRAIN WAS INSERTED INTO THE POCKET. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Medical device site infection; Pain; Swelling/ Edema

  MAUDE report 21395201 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY FIVE WEEKS POST IMPLANT THAT THE PATIENT EXPERIENCED INFECTION. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED OTHER SYMPTOMS - POCKET EROSION AND HEMATOMA. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED BY A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Pocket Erosion; Unspecified Infection

  MAUDE report 21363180 ↗

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-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• 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-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-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-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• 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-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.