Advisa SR MRI™ SureScan™ A3SR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 230 adverse event reports that list this exact device (DI 00643169402669), received between Feb 9, 2017 and Sep 16, 2026 — classified as 16 deaths, 120 injuries, 94 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (46 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 230 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Premature Discharge of Battery

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds leading to battery depletion of the Implantable Pulse Generator (IPG). The lead and IPG 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 50787855 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a pocket infection with discomfort. The Implantable Pulse Generator (IPG) system was explanted a replaced with a Leadless implantable pulse generator (IPG). No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 50342673 ↗
• MalfunctionJun 4, 2026Pacing Problem

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

  Patient problems: Bradycardia

  MAUDE report 25388144 ↗
• InjuryNov 28, 2025Pacing Problem; Pacing Problem

  IT WAS FURTHER NOTED THAT THE RV LEAD AND IPG WERE EXPLANTED AND REPLACED.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 23670614 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23645757 ↗
• DeathNov 12, 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. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS LEFT IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23530967 ↗
• MalfunctionSep 4, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENTS REMOTE MONITOR DOES NOT ALLOW THEM TO COMPLETE THERE TRANSMISSION, AND EACH TIME IS ATTEMPTED IT SHOWS ERROR CODE. 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 22962521 ↗
• InjuryAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS IN A SERIOUS ACCIDENT AND BELIEVED THEIR IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING DURING THE ACCIDENT. IT WAS ALSO NOTED THE PATIENT PASSED OUT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 22921038 ↗
• DeathAug 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT DIED. IT WAS FURTHER NOTED THAT THE "DEVICE WAS NOT SATISFACTORY AND CONTRIBUTED TO THE PATIENTS PASSING". THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22871379 ↗
• InjuryJul 3, 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 WITH PURULENT DISCHARGE/PUS NOTED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; Purulent Discharge

  MAUDE report 22392604 ↗
• InjuryJan 10, 2025Pacing Problem; Pacing Problem

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

  Patient problems: Bradycardia

  MAUDE report 21122275 ↗
• MalfunctionJan 6, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEART RATE BELOW THE LOWER RATE 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 21077712 ↗
• InjuryDec 2, 2024Misconnection; Misconnection

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE AND SYNCOPE. IT WAS ALSO REPORTED THAT THE THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE AND WAS DROPPING BEATS. THE LEAD WAS REPROGRAMMED. RISING THRESHOLDS INTERMITTENT LOSS OF CAPTURE WAS STILL NOTED ON THE LEAD.  DURING THE CHANGEOUT PROCEDURE, WHEN THE RV LEAD WAS TESTED, HIGH OUT OF RANGE IMPEDANCE WAS NOTED POSSIBLY DUE TO THE DEVICE EXHIBITING CONNECTOR PORT ISSUES. THE LEAD WAS CAPPED, AND DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole; No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 20818255 ↗
• MalfunctionNov 12, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT ERROR CODE 3269 APPEARED IN THE APPLICATION INDICATING A BLUETOOTH FAILURE OCCURRED. IT WAS ALSO REPORTED THAT THERE WAS NO TELEMETRY WITH THE IMPLANTABLE PULSE GENERATOR (IPG). TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. REFERRED PATIENT TO THE CLINIC. THE SMART READER AND THE IPG REMAIN IN USE. THE SMART READER APPLICATION 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 20665370 ↗
• MalfunctionOct 16, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED, THAT THERE WAS A CONCERN THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING CORRECTLY. 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 20462450 ↗
• MalfunctionAug 27, 2024Pacing Problem; Pacing Problem

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

  Patient problems: Bradycardia

  MAUDE report 20073842 ↗
• MalfunctionAug 23, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED LOSS OF TELEMETRY. 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 20048859 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST IMPLANT, THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. PURULENT LIQUID WAS DISCHARGED WITH THE INITIAL EXCISION AND FOUND THROUGHOUT THE POCKET . THE INCISION WAS EXTENDED TO ALLOW EXPLORATION OF THE PUS AND PURULENT TISSUE WAS EXCISED. THE ORGANISM WAS IDENTIFIED AS BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Pocket Erosion; Purulent Discharge

  MAUDE report 19496433 ↗
• MalfunctionMay 22, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN AND PACING BELOW THE SET LIMITS OF THE IPG WITH THE IPG NOT KICKING IN AT THE LOWER RATE. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Chest Pain

  MAUDE report 19368764 ↗
• MalfunctionMar 18, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS AND PACING BELOW THE SET LIMITS 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; Muscle Weakness/Atrophy

  MAUDE report 18923842 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION INVOLVING THE TRICUSPID VALVE. THE IMPLANTABLE PULSE GENERATOR (IPG) 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 18901603 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS INFECTION WITH DISCOMFORT, REDNESS, TENDERNESS AND SWELLING ABOVE THE IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT SITE. THE PATIENT ALSO EXPERIENCED ATRIAL FIBRILLATION (AF), HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFPEF), HYPERTENSION, HYPERLIPIDEMIA, GOUT, MSSA BACTEREMIA COMPLICATED BY EPIDURAL ABSCESS, SPLENIC ABSCESS, L-S SPINE OSTEOMYELITIS AND PSOAS ABSCESS. THE IPG SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Abscess; Atrial Fibrillation; Bacteremia; Bacterial Infection; Discomfort; Erythema; Heart Failure/Congestive Heart Failure; High Blood Pressure/ Hypertension; Swelling/ Edema

  MAUDE report 18701393 ↗
• MalfunctionFeb 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT STATED THE IMPLANTABLE PULSE GENERATOR (IPG) IS "TURNING ON AND OFF." 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 18684028 ↗
• InjuryJan 18, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT FELT LIKE PACEMAKER WAS FUNNY AND THEY HAD A SYNCOPAL EPISODE AND FALL AT HOME. THE CARELINK TRANSMISSION INDICATED THERE WAS A DECREASE IN PACING PERCENTAGE FOR THE PAST MONTH, UNKNOWN IF RELATED TO PATIENT SYMPTOMS. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 18533383 ↗
• DeathJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DECEASED. THERE WAS AN ALLEGATION FROM THE PATIENT'S FAMILY MEMBER THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS RELATED TO THE PATIENT'S DEATH. A CAUSE OF DEATH WAS REQUESTED BUT WAS NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 18469223 ↗

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-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-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• 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-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 Number
• 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-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.