Micra™ VR2 MC2VR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 483 adverse event reports that list this exact device (DI 00763000078683), received between Aug 2, 2023 and Sep 29, 2026 — classified as 23 deaths, 177 injuries, 283 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (141 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. 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 483 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Leak/Splash

  The delivery system was returned to the manufacturer, analyzed, and tested out of specification. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928833 ↗
• InjurySep 25, 2026Intermittent Capture; Capturing Problem; High Capture Threshold

  It was reported that six days post implant of a Leadless implantable pulse generator (IPG) the patient experienced asystole and cardiac arrest. It was reported that the Leadless IPG exhibited intermittent loss of capture and rising, high thresholds. The Leadless IPG was reprogrammed and remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Asystole; Cardiac Arrest

  MAUDE report 50895250 ↗
• MalfunctionSep 24, 2026Deformation Due to Compressive Stress

  It was reported that during implant, the delivery system sheath kinking whole crossing valve from the internal jugular approach. A new micra was implanted with the femoral approach. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881019 ↗
• MalfunctionSep 18, 2026Intermittent Capture; Unstable Capture Threshold

  It was reported that since implant, the leadless Implantable Pulse Generator (IPG) exhibited fluctuating thresholds and possible loss of intermittent capture. 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 50815524 ↗
• InjurySep 15, 2026Failure to Capture; Pacing Problem

  It was reported that the patient experienced bradycardia, shortness of breath and swelling. It was noted there was a loss of capture. and pacing below the lower rate. The Leadless implantable pulse generator (IPG) was programmed off and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Dyspnea; Swelling/ Edema

  MAUDE report 50773273 ↗
• DeathSep 10, 2026Failure to Capture; Migration or Expulsion of Device; Pacing Problem; Under-Sensing; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

  It was reported that the leadless Implantable Pulse Generator (IPG) dislodged and migrated at some point after the hospital discharge. The patient sent a transmission when setting up the home monitor and threshold was high. The physician brought the patient back into the clinic to interrogate the device where it was noted to be non-capture at max output and also non-sensing even at most sensitive setting. The patient was sent for a chest x-ray where it was found that the device had dislodged and migrated deep into the pulmonary artery. The patient was admitted and taken to the cath lab to attempt retrieval but, as it was being pulled back toward the pulmonic valve, the patient became unstable with a pericardial bleed, cardiac pause, and a code blue was called. An emergency sternotomy was performed. The device was not able to be removed and the patient was placed on ECMO and sent to the cardiac intensive care unit (ICU). The patient was taken back to the operating room due to excessive blood output in their chest tubes and was found to have a tear in the atrium which was repaired and was sent back to the ICU. The patient was weaned off of ECMO but due to multi-system organ dysfuncti

  Patient problems: Cardiac Arrest; Cardiac Perforation; Cardiogenic Shock; Encephalopathy; Multiple Organ Dysfunction Syndrome; Non specific EKG/ECG Changes; Renal Failure; Respiratory Failure; Valvular Insufficiency/ Regurgitation

  MAUDE report 50714579 ↗
• MalfunctionSep 8, 2026Pacing Problem

  It was reported by the patient that the Leadless implantable pulse generator (IPG) was pacing below the lower set rate. 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 50671253 ↗
• InjurySep 8, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Leadless implantable pulse generator (IPG) was removed and replaced for an unknown reason. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50665830 ↗
• InjurySep 7, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50650294 ↗
• MalfunctionSep 4, 2026Appropriate Device Problem Term/Code Not Available

  It was reported by the patient representative that the Leadless implantable pulse generator (IPG) was 'not functioning effective' and was contributing to the patient's breathing difficulties. The leadless IPG remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Dyspnea

  MAUDE report 50611691 ↗
• MalfunctionSep 2, 2026Failure to Capture; Use of Device Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50566510 ↗
• InjurySep 2, 2026Intermittent Capture; Capturing Problem

  It was reported a few weeks post implant of the Leadless implantable pulse generator (IPG) the thresholds began to rise and there was intermittent capture. The leadless 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 50559247 ↗
• MalfunctionSep 1, 2026Activation, Positioning or Separation Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50538585 ↗
• InjuryAug 26, 2026Material Integrity Problem; High Capture Threshold

  It was reported one day post Leadless implantable pulse generator (IPG) implant, the thresholds were noted to be high and it appears that only two tines were engaged. 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 50450341 ↗
• MalfunctionAug 24, 2026Failure to Capture; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50408706 ↗
• InjuryAug 24, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the patient had a "bad fall" and was "tired all the time". The patient was hospitalized. No further patient complications have been reported as a result of this event.

  Patient problems: Fall; Fatigue

  MAUDE report 50404779 ↗
• MalfunctionAug 20, 2026Intermittent Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50351255 ↗
• MalfunctionAug 20, 2026Mechanical Problem; Use of Device Problem; Device Dislodged or Dislocated; Positioning Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50347974 ↗
• InjuryAug 20, 2026Failure to Capture; Capturing Problem; High Capture Threshold

  It was reported that the patient experienced shortness of breath. It was further reported that the leadless Implantable Pulse Generator (IPG) exhibited loss of capture. It was noted that the Leadless IPG exhibited increasing and high thresholds. The Leadless IPG was inactivated and replaced. No patient complications have been reported as a result of this event.

  Patient problems: Dyspnea

  MAUDE report 50346370 ↗
• MalfunctionAug 19, 2026Reset Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50323998 ↗
• MalfunctionAug 10, 2026Failure to Capture; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50190793 ↗
• InjuryAug 7, 2026Failure to Capture; Capturing Problem; High Capture Threshold

  It was reported that approximately two weeks after implant, the Leadless implantable pulse generator (IPG) exhibited loss of capture resulting in high and rising thresholds. Patient experienced bradycardia, dizziness and near syncope as a result. The leadless IPG was programmed off and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Dizziness; Presyncope

  MAUDE report 50171079 ↗
• InjuryAug 7, 2026Intermittent Capture; High Capture Threshold

  It was reported two weeks post implant that the Leadless implantable pulse generator (IPG) exhibited intermittent capture and high thresholds due to patient anatomy. The leadless 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 50170613 ↗
• InjuryJul 14, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENTS REPRESENTATIVE THAT THE PATIENT WAS HOSPITALIZED DUE TO A STROKE. THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 25810375 ↗
• DeathJul 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), THE PATIENT EXPERIENCED A CARDIAC PERFORATION OF THE RIGHT VENTRICLE AND PERICARDIAL EFFUSION. BLOOD PRESSURE DROPPED SHORTLY AFTER FIRST RECAPTURE FROM THE FIRST DEPLOYMENT LOCATION. THE PATIENT WAS TAPPED WITHIN FIVE MINUTES OF PRESSURES DROPPING AND AN ECHOCARDIOGRAM WAS PERFORMED AND CONFIRMED EFFUSION. CARDIOPULMONARY RESUSCITATION WAS PROVIDED MULTIPLY TIMES UNTIL A THORACOTOMY WAS PERFORMED UNTIL PATIENT WAS PRONOUNCED DEAD.

  Patient problems: Cardiac Perforation; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 25759760 ↗

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-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-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.