Medtronic Micra PacemakerRecalls & reported problems across all models

We found 6 models of Medtronic Micra Pacemaker by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 6,910 adverse event reports in the FDA's MAUDE database, received between Oct 10, 2014 and Sep 30, 2026 — classified as 517 deaths, 2,724 injuries, 3,669 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (1,369 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Medtronic Micra Pacemaker recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 6, 2019Terminated

   Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.

   Z-2492-2019 · Root cause: Other · names 2 of these models · Recall details · FDA record ↗

Most reported Medtronic Micra Pacemaker problems

Medtronic Micra Pacemaker models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Micra™ AV MC1AVR1

  Leadless pacemaker
  189 deaths2,297 reports
• Micra™ MC1VR01US

  Leadless pacemaker
  1 recall157 deaths2,106 reports
• Micra™ AV2 MC2AVR1

  Leadless pacemaker
  95 deaths1,457 reports
• Micra™ VR2 MC2VR01

  Leadless pacemaker
  23 deaths483 reports
• Micra™ MC1VR01US

  Leadless pacemaker
  1 recall22 deaths379 reports
• Micra™ Introducer MI2355A

  INTRODUCER, CATHETER
  31 deaths188 reports

Recent Medtronic Micra Pacemaker adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Unspecified Infection

  MAUDE report 50946252 ↗
• MalfunctionSep 29, 2026Intermittent Capture; Failure to Capture; Pacing Problem

  It was reported that the patient experienced bradycardia. The leadless Implantable Pulse Generator (IPG) exhibited possible pacing b elow the lower rate, loss of capture and intermittent capture. The device remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia

  MAUDE report 50935743 ↗
• 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 ↗
• 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 ↗
• 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 25, 2026Use of Device Problem; Human-Device Interface Problem

  It was reported that during implant the leadless Implantable Pulse Generator (IPG) dislodged after the tether was cut and was sat in mid right atrium at the tip of the delivery catheter. The device then became free of the tether and moved and was then observed in the Right pulmonary artery (RPA). The delivery system was removed and attempted retrieval using large curve agilis catheter, gooseneck snare and deflectable diagnostic catheter, then AL1 with wire to guide to the RPA branch. They were unable to get to the branch with the device with the wire, and on contrast injection no contrast reached the branch with the device in. Suspected dissection of RPA branch on fluoroscopy with small lacerations in the right upper RPA. The device embolized in RPA branch and the patient had occasional coughing and mild chest discomfort. It was also noted that the introducer was used more than six months after the use by date. The patient will be monitored with the device remaining in the patient. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Laceration(s); No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 50895165 ↗
• 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 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 ↗

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