Micra™ AV2 MC2AVR1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,457 adverse event reports that list this exact device (DI 00763000078645), received between Jun 7, 2023 and Sep 30, 2026 — classified as 95 deaths, 534 injuries, 828 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (281 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 1,457 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Unspecified Infection

  MAUDE report 50946252 ↗
• DeathSep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported during implant of the Leadless implantable pulse generator (IPG), the patient coded mid-procedure, while attempting to locate a good position with the leadless IPG Delivery System (DS) for deployment of the device. Their blood pressure dropped and they experienced asystole. Cardiopulmonary resuscitation and an ultrasound was performed indicating Right Ventricular (RV) cardiac perforation resulting in a pericardial effusion and cardiac tamponade. Pericardiocentesis, resuscitative measures and surgical inte rvention with cardiothoracic surgical input, but were performed but were unsuccessful. The patient ultimately passed away.

  Patient problems: Asystole; Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 50915700 ↗
• MalfunctionSep 28, 2026Over-Sensing; Under-Sensing

  It was reported that the Leadless implantable pulse generator (IPG) exhibited mechanical undersensing and some oversensing issues. 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 50913702 ↗
• MalfunctionSep 28, 2026Failure to Capture; Under-Sensing; Capturing Problem; Positioning Problem; Unstable Capture Threshold

  It was further reported that the leadless IPG exhibited unstable thresholds. Once the tether was cut for the first deployment the th resholds were fine, but subsequently rose and kept rising. The IPG was removed with a snare.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913678 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during the implant procedure of a Leadless implantable pulse generator (IPG) the patient experienced perforation of the Right Ventricle and pericardial effusion. The leadless IPG was attempted/not used. No further patient complications have been reported as a result of this event.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50895347 ↗
• MalfunctionSep 25, 2026Positioning Problem

  It was reported that during the implant procedure of a Leadless implantable pulse generator (IPG) the leadless IPG exhibited placement difficulty. It was reported that the delivery system exhibited out of plane deflection. The Leadless IPG 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 50895318 ↗
• MalfunctionSep 25, 2026Failure to Capture

  It was reported post-operatively that the Leadless implantable pulse generator (IPG) exhibited loss of capture on current electrograms (EGM). 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 50894781 ↗
• MalfunctionSep 25, 2026Impedance Problem

  It was reported post-operatively that the Leadless implantable pulse generator (IPG) exhibited increased impedances. 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 50894683 ↗
• MalfunctionSep 25, 2026Pacing Problem

  It was reported by the patient post-operatively that they experienced bradycardia and problems with their heart showing heart rates falling below fifty beats per minute and as low as forty two and forty four beats per minute. The Leadless implantable pulse generator (IPG) was pacing below the lower rate. The leadless IPG remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia

  MAUDE report 50894550 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported approximately two months post implant that the patient experienced endocarditis. The Leadless implantable pulse generator (IPG) was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Endocarditis

  MAUDE report 50894533 ↗
• InjurySep 24, 2026Intermittent Capture; Failure to Capture; Capturing Problem; Device Dislodged or Dislocated; High Capture Threshold

  It was reported that the patient had a syncopal episode. It was noted that patient experienced bradycardia, pain and hematoma. Patient was externally paced. It was noted that there was rising thresholds, intermittent capture and high thresholds. It was noted the device was losing contact with the myocardial tissue resulting in failure to capture. The Leadless implantable pulse generator (IPG) replaced with a new system.

  Patient problems: Bradycardia; Hematoma; Pain; Syncope/Fainting

  MAUDE report 50886479 ↗
• MalfunctionSep 24, 2026Pacing Problem

  It was reported that the patient experienced dizziness and that the Leadless implantable pulse generator (IPG) was pacing below the lower set rate. The leadless IPG remains in in use. No further patient complications have been reported as a result of this event.

  Patient problems: Dizziness

  MAUDE report 50886222 ↗
• MalfunctionSep 24, 2026Mechanical Problem

  It was reported that during implant the Leadless implantable pulse generator (IPG) exhibited rising thresholds and undersensing. Recapture difficulty was noted and a snare was required. The leadless IPG 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 50882386 ↗
• MalfunctionSep 24, 2026Failure to Capture; Under-Sensing; Capturing Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem; High Capture Threshold

  It was reported that during implant the Leadless implantable pulse generator (IPG) exhibited rising thresholds and undersensing. Recapture difficulty was noted and a snare was required. The leadless IPG and delivery system were 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 50882347 ↗
• MalfunctionSep 24, 2026Activation, Positioning or Separation Problem

  It was reported that during the implant procedure of a Leadless implantable pulse generator (IPG) the delivery system exhibited a de ployment issue. The deployment button was broken and the leadless IPG was unable to be deployed. It was noted that when the physician attempted to deploy the device the deployment button moved but the device remained completely seated inside the cup. The delivery system was removed and it was noted that the leadless IPG was stuck inside the catheter at the valve. The leadless IPG was removed from the catheter by pulling on the tether. The leadless IPG was attempted/ not used and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880679 ↗
• MalfunctionSep 24, 2026Pacing Problem

  It was reported by the patient representative that the patient experienced a heart rate below the programmed lower rate of the leadless Implantable Pulse Generator (IPG). The IPG remains in use. No patient complications have been reported as a result of this event.

  Patient problems: Bradycardia

  MAUDE report 50880428 ↗
• InjurySep 24, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the leadless Implantable Pulse Generator (IPG) was not functioning within normal tolerances. The IPG was explanted and replaced with a transvenous pacing system. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880323 ↗
• InjurySep 23, 2026Intermittent Capture; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

  It was reported during implant that physician deployed the leadless Implantable Pulse Generator (IPG) and delivery system (DS) three times where it exhibited high thresholds and intermittent capture. About one hour post implant the patient experienced pericardial effusion and underwent a procedure for drainage. The leadless IPG remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Pericardial Effusion

  MAUDE report 50867393 ↗
• DeathSep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that approximately six hours post-implant of a Leadless implantable pulse generator (IPG) the patient became severely hypoxic and experienced cardiac arrest. A bedside echocardiogram was performed. The physician indicated that a pulmonary embolism was the likely cause. The patient passed away.

  Patient problems: Cardiac Arrest; Hypoxia; Pulmonary Embolism

  MAUDE report 50865740 ↗
• InjurySep 18, 2026Failure to Capture; Device Dislodged or Dislocated

  It was reported that the patient experienced bradycardia.  It was noted that there was no capture and that the Leadless implantable pulse generator (IPG) dislodged after a tricuspid valve replacement surgery. The leadless IPG was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia

  MAUDE report 50817931 ↗
• InjurySep 18, 2026Failure to Capture; Capturing Problem; High Capture Threshold

  It was reported that the patient experienced asystole, bradycardia and dizziness. It was reported that the Leadless implantable pulse generator (IPG) exhibited rising and high thresholds and loss of capture. The Leadless implantable pulse generator (IPG) was reprogrammed and replaced with a transvenous IPG system and remains in the patient. No further patient complications have been reported as a result of this event.

  Patient problems: Asystole; Bradycardia; Dizziness

  MAUDE report 50814321 ↗
• MalfunctionSep 18, 2026High Capture Threshold; Unstable Capture Threshold; Unstable Impedance

  It was reported approximately one week post implant that the leadless Implantable Pulse Generator (IPG) exhibited fluctuating impedances, fluctuating thresholds and high 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 50814247 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient died. During the procedure, the leadless implantable pulse generator (IPG) and delivery system were advanced into the right ventricle, and contrast imaging was used to confirm septal positioning. However, the leadless IPG was not deployed, and the patient subsequently developed a pericardial effusion. The crash team initiated resuscitative efforts to stabilize the patient, but these attempts were unsuccessful.

  Patient problems: Pericardial Effusion

  MAUDE report 50801644 ↗
• MalfunctionSep 17, 2026High impedance; Positioning Problem

  It was reported that intra operatively during the placement of the Leadless implantable pulse generator (IPG), High impedance was noted on multiple deployments. The deployment button on the delivery system was not working. Recapturing difficulty was noted and the system was eventually successfully recaptured. The Leadless implantable pulse generator (IPG) 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 50799483 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during the implant procedure of a Leadless implantable pulse generator (IPG) the patient experienced right vent ricular cardiac perforation. Pericardiocentesis was performed but the patient passed away.

  Patient problems: Cardiac Perforation

  MAUDE report 50799233 ↗

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