Azure™ XT SR MRI SureScan™ W1SR01 (UDI 00643169871953)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169871953), received between Mar 23, 2018 and Jan 10, 2025 — classified as 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2025Capturing Problem; Device Sensing Problem; Capturing Problem; Device Sensing Problem

  IT WAS REPORTED THAT IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO SENSING AND NO CAPTURE. IT WAS ALSO REPORTED THAT RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED AND EXHIBITED NO RV CAPTURE AND DIMINISHED SENSING. DEVICE WAS EXPLANTED AND REPLACED. LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123594 ↗
• InjuryApr 4, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT AN INCREASE IN IMPEDANCE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD AND HIGH IMPEDANCE. THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A PACING ISSUE. THE RV LEAD WAS CAPPED AND 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 16674471 ↗
• MalfunctionJan 10, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOW HEART RATE. IT WAS ALSO NOTED THAT 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. COMPLAINT: IT WAS REPORTED THAT THE CURRENT AND LIFETIME COUNTERS WERE OFF ON THE REMOTE MONITORING NETWORK. TROUBLESHOOTING: TICKET CREATED. OUTCOME: OTHER.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 16129243 ↗
• InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION. THE IMPLANTABLE PULSE GENERATOR (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: Drug Resistant Bacterial Infection

  MAUDE report 15657283 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE ORGANISM IDENTIFIED WAS METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA). 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: Bacterial Infection

  MAUDE report 15504817 ↗
• MalfunctionJun 18, 2021Pacing Problem; Pacing Problem

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

  Patient problems: Bradycardia

  MAUDE report 12025613 ↗
• MalfunctionMar 5, 2021Reset Problem; Reset Problem

  IT WAS FURTHER REPORTED THAT PATIENT EXPERIENCED PAIN WHILE RAISING ARM AND THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED DUE TO AN UPGRADE TO A DUAL CHAMBER IPG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419614 ↗
• InjuryDec 18, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) EPICARDIAL LEAD EXHIBITED HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE ABDOMINAL, SINGLE CHAMBER IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION POST TWO AND A HALF YEARS, DUE TO HIGH THRESHOLDS OF RV LEAD. BOTH THE RV LEAD AND THE ABDOMINAL IPG WERE INACTIVATED AND REPLACED WITH A LEADLESS IPG. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11037710 ↗
• 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 Known Impact Or Consequence To Patient

  MAUDE report 9088165 ↗
• InjuryAug 20, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SETSCREW CAME OUT OF THE DEVICE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8909449 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS FELLING STIMULATION ON A DAILY BASIS AT CONSISTENT TIMES. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation; Undesired Nerve Stimulation

  MAUDE report 8738677 ↗
• MalfunctionJun 25, 2019Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED "PAUSES IN PACING" WHEN THE PATIENT CHECKS THEIR PULSE. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 8730611 ↗
• InjuryMay 20, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE PATIENT FELT CHEST PAIN AND IT WAS LIKELY EXTRACARDIAC STIMULATION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPROGRAMMED. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Muscle Stimulation

  MAUDE report 8623839 ↗
• MalfunctionMay 8, 2019Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CARDIAC COMPASS HAD INVALID DATA FOR 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 8590002 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE INCISION SITE THAT HAD BEEN PROGRESSIVELY WORSENING. INCREASED REDNESS AT THE IMPLANT SITE AND A SUBJECTIVE FEVER AND CHILLS WERE NOTED. AN IMPLANTABLE PULSE GENERATOR (IPG) POCKET INFECTION WAS INDICATED. THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS AND THE INFECTION SITE BEGAN DRAINING WITH SEROSANGUINEOUS DRAINAGE. THE IPG SYSTEM WAS EXTRACTED WITH PUS NOTED IN THE POCKET. CULTURES FROM THE POCKET TESTED AS STAPHYLOCOCCUS AUREUS. THE PATIENT CONTINUED ON IV ANTIBIOTICS AND THEN TRANSITIONED TO ORAL ANTIBIOTICS AT DISCHARGE. THERE IS NO INDICATION THE PATIENT WILL RECEIVE A NEW PACEMAKER AT THIS TIME. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8374339 ↗
• InjuryJun 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED DUE TO A POCKET INFECTION. THE WOUND WAS OPEN AND DRAINING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7565731 ↗
• MalfunctionMar 23, 2018High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER THE IMPLANTABLE PULSE GENERATOR (IPG) WAS CONNECTED, IT INDICATED HIGHER THRESHOLDS THAN WHAT WAS OBSERVED THROUGH THE ANALYZER. THE IPG WAS NOT USED AND ANOTHER IPG WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7365917 ↗

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