Micra™ AV MC1AVR1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,297 adverse event reports that list this exact device (DI 00763000078621), received between Mar 11, 2020 and Sep 30, 2026 — classified as 189 deaths, 962 injuries, 1,146 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (354 reports).

4 other recalls cover devices cleared under the same FDA submission (P150033); 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 2,297 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Pericarditis; Rupture; Transient Ischemic Attack; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 50948990 ↗
• MalfunctionSep 25, 2026Under-Sensing

  It was reported that the Leadless implantable pulse generator (IPG) exhibited a under sensed beat on current electrograms (EGM) with no marker seen indicating sensing of ventricular sensed event. The leadless 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 50894794 ↗
• MalfunctionSep 17, 2026High Capture Threshold; Unstable Capture Threshold

  It was reported that the leadless Implantable Pulse Generator (IPG) exhibited significant variability in capture threshold trends, high thresholds and R wave amplitude variability was also noted on trends. The leadless 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 50800613 ↗
• InjurySep 16, 2026Premature Discharge of Battery

  It was reported that the leadless Implantable Pulse Generator (IPG) exhibited premature battery depletion. The leadless IPG was explanted and replaced with a transvenous IPG system. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785376 ↗
• InjurySep 2, 2026Premature Discharge of Battery

  It was reported that the Implantable Pulse Generator (IPG) exhibited premature battery depletion. The device was inactivated and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564413 ↗
• InjuryAug 26, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the patient experienced a Ventricular Fibrillation (VF) arrest which was believed to be caused by an early, extra heartbeat landing directly on the T-wave of the previous heartbeat. The Leadless implantable pulse generator (IPG) was inactivated and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Ventricular Fibrillation

  MAUDE report 50455528 ↗
• InjuryAug 23, 2026Premature Discharge of Battery

  It was reported that the Leadless implantable pulse generator (IPG) exhibited premature battery depletion. The leadless IPG was inactivated and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50397586 ↗
• MalfunctionAug 9, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50188570 ↗
• MalfunctionAug 9, 2026Failure to Capture; Pacing Problem; Under-Sensing; High Capture Threshold

  It was reported that the Leadless implantable pulse generator (IPG) exhibited undersensing resulting in unnecessary ventricular pacing. Loss of capture resulting in high thresholds were noted as well. The leadless 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 50188545 ↗
• InjuryAug 7, 2026Premature Discharge of Battery

  It was reported that the leadless Implantable Pulse Generator (IPG) exhibited premature battery depletion. The IPG was inactivated and replaced and remains in the patient. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50172228 ↗
• InjuryJul 13, 2026Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WAS SYMPTOMATIC FROM INAPPROPRIATE VENTRICULAR PACING WITH INTERMITTENT ATRIOVENTRICULAR DESYNCHRONY AS A RESULT OF SUBOPTIMAL MECHANICAL ATRIAL SENSING ON THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE LEADLESS IPG WAS PROGRAMMED OFF AND REPLACED WITH A TRANSVENOUS IPG 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 25793112 ↗
• MalfunctionJul 13, 2026Failure to Capture; Capturing Problem

  Patient problems: Bradycardia; Nausea

  MAUDE report 25793057 ↗
• MalfunctionJul 2, 2026Failure to Capture

  IT WAS REPORTED THAT LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) CAPTURE COULD NOT BE CONFIRMED. THE LEADLESS 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 25691451 ↗
• InjuryJun 30, 2026Premature Discharge of Battery; High Capture Threshold

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED HIGH THRESHOLDS WHICH LEAD TO SUSPECTED EARLY BATTERY DEPLETION. THE LEADLESS IPG WAS INACTIVATED AND REPLACED WITH A TRANSVENOUS SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25662938 ↗
• InjuryJun 18, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS SYMPTOMATIC WITH THE ATRIOVENTRICULAR (AV) CONDUCTION MODE SWITCH LOWER RATE. THE FEATURE WAS PROGRAMMED OFF AND THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH, DIZZINESS AND SOME CHEST PAIN. THE DEVICE WAS REPROGRAMMED AGAIN AS PROGRAMMING THE FEATURE OFF DID NOT RESOLVE THE SYMPTOMS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Dizziness; Dyspnea

  MAUDE report 25547515 ↗
• MalfunctionJun 18, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WAS HAVING HEART RATES IN THE THIRTIES WITH NO VISIBLE ECTOPY TO CONTRIBUTE TO LOWER HEART RATES ON RHYTHM STRIP. IN ADDITION, THERE WAS LOW AMPLITUDE R WAVES NOTED AND CONCERNS FOR UNDERSENSING. THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 25543366 ↗
• MalfunctionJun 4, 2026Failure to Capture; Pacing Problem; Capturing Problem

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED LOSS OF CAPTURE, INCREASED THRESHOLDS AND WAS PACING BELOW THE LOWER RATE. THE DEVICE 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 25389801 ↗
• MalfunctionMay 22, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH. IT WAS FURTHER NOTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) "DIDN¿T WORK¿ AS ¿ADVERTISED¿. THE LEADLESS IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 25252190 ↗
• MalfunctionMay 19, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED HIGH THRESHOLDS AND NO CAPTURE. THE DEVICE 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 25213062 ↗
• InjuryMay 18, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND DEVELOPED SINUS NODE DYSFUNCTION SOMETIME AFTER THE IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE DEVICE WAS INACTIVATED AND REPLACED WITH A TRANSVENOUS SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25199122 ↗
• InjuryMay 15, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PHYSICIAN WAS NOT HAPPY WITH HOW THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS FUNCTIONING, AND SUBSEQUENTLY A COMPETITOR PACING SYSTEM WAS IMPLANTED. THE LEADLESS IPG WAS ABANDONED AND REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25181238 ↗
• InjuryMay 12, 2026Premature Discharge of Battery; High Capture Threshold

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED HIGH THRESHOLDS AND PREMATURE BATTERY DEPLETION. THE LEADLESS IPG WAS INACTIVATED AND REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146798 ↗
• InjuryMay 11, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RUN OF VENTRICULAR TACHYCARDIA (VT) AND THEIR HEART RATE WAS DIPPING INTO THE THIRTIES AND FORTIES AT NIGHT AND DURING THE DAY. VENTRICULAR BIGEMINY WAS ALSO NOTED. THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) REACHED EARLY ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS INACTIVATED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Tachycardia

  MAUDE report 25141344 ↗
• MalfunctionMay 5, 2026Premature Discharge of Battery; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT'S LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED RAPID BATTERY DEPLETION DUE TO HIGH OUTPUTS DURING THE DEVICE'S EARLY LIFE. THE LEADLESS 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 25078967 ↗
• MalfunctionApr 24, 2026Capturing Problem

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED RISING THRESHOLDS. THE LEADLESS 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 24975926 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150033. 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-2492-2019 · Aug 6, 2019 · Terminated
  Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
• Z-2493-2019 · Aug 6, 2019 · Terminated
  Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.