Micra™ MC1VR01US (UDI 00643169529748)Recalls & reported problems

Summary

The FDA's MAUDE database contains 379 adverse event reports that list this exact device (DI 00643169529748), received between Dec 9, 2016 and May 12, 2026 — classified as 22 deaths, 207 injuries, 150 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (99 reports).

1 FDA recall record name this device's identifier.

3 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.

Recalls naming this device

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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 379 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Under-Sensing

  IT WAS REPORTED THAT THERE WAS RIGHT VENTRICULAR (RV) UNDERSENSING. THE LEADLESS 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 25147531 ↗
• MalfunctionApr 20, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE LEADLESS IPG EXHIBITED A TELEMETRY DROPOUT AND SHORTENED MARKERS ON THE CURRENT ELECTROGRAMS (EGM). 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 24925419 ↗
• MalfunctionJan 5, 2026Under-Sensing; Capturing Problem; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED SIGNIFICANT INCREASE IN RIGHT VENTRICULAR (RV) OUTPUT WITH VARIABLE THRESHOLDS. R WAVE UNDERSENSING WAS OBSERVED AND A CLUSTER OF INCREASED THRESHOLD IN A SHORT TIME FRAME WAS ALSO NOTED. 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 23954990 ↗
• InjuryAug 1, 2025Failure to Capture; Human-Device Interface Problem; Failure to Capture; Human-Device Interface Problem

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT CAPTURING AFTER IT WAS IMPLANTED. IT WAS ALSO NOTED THAT THE EXPIRATION DATE OF THE LEADLESS IPG WAS EXCEEDED. THE LEADLESS IPG WAS PROGRAMMED OFF. A NEW IPG AND RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22685478 ↗
• InjuryJul 21, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A THROMBUS. THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THIS PATIENT IS PART OF A CLINICAL STUDY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22552985 ↗
• MalfunctionMay 19, 2025Extracardiac stimulation; Extracardiac stimulation

  THE PATIENT REPORTED THAT THEY EXPERIENCED A STRONG PUNCH OF IMPACT OCCURRING OVER THEIR LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT BELIEVES THAT THE IPG IMPULSE WAS STIMULATING THE TOP OF THEIR RECTUS ABDOMINUS, CAUSING THEM TO FEEL THIS PUNCH. THE LEADLESS IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 22042441 ↗
• MalfunctionMay 15, 2025Capturing Problem; Capturing Problem

  IT WAS NOTED THAT THE LEADLESS IPG INCREASING THRESHOLDS WERE FALSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028913 ↗
• MalfunctionMar 27, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) DID NOT MEET EXPECTED BATTERY LONGEVITY, AND DEPLETED RAPIDLY WITHIN THE SPACE OF NINE MONTHS. 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 21707023 ↗
• MalfunctionDec 31, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT A PATIENT WITH AN IMPLANTABLE PACEMAKER DEVICE EXPERIENCED ELEVATED SHORT V-V INTERVALS. THE LEADLESS 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 21047146 ↗
• InjuryDec 9, 2024Premature Discharge of Battery; Pacing Problem; Output Problem; Premature Discharge of Battery; Pacing Problem; Output Problem

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A LONGEVITY ESTIMATOR DISCREPANCY AND PREMATURE DEPLETION. THE PATIENT REQUIRED AN EMERGENCY REPLACEMENT AND WAS NOTED TO HAVE 12 SECOND PAUSES ON TELEMETRY DUE TO FAILURE TO PACE WITH A SLOWER HEART RATE AND PRE-SYNCOPE. THE LEADLESS IPG WAS INACTIVATED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes; Presyncope

  MAUDE report 20877201 ↗
• InjuryNov 28, 2024Battery Problem; Capturing Problem; Battery Problem; Capturing Problem

  IT WAS REPORTED THAT THE THRESHOLDS HAD INCREASED ON THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). IT WAS ALSO NOTED THAT THE LEADLESS IPG WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). 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 20805673 ↗
• MalfunctionNov 14, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION ON THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). 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 20682203 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH FATIGUE, WEAKNESS AND SEPTIC ENDOCARDITIS. THE PATIENT WAS GIV EN INTRAVENOUS (IV) ANTIBIOTICS AS WELL AS ORAL ANTIBIOTICS. THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Fatigue; Muscle Weakness/Atrophy; Sepsis

  MAUDE report 20350691 ↗
• InjuryJan 19, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND WAS PACING AT THE UPPER SENSOR RATE OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), WHICH WAS POSSIBLE PACEMAKER MEDIATED. THE LEADLESS IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Dyspnea; Tachycardia

  MAUDE report 18543531 ↗
• InjuryJan 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENTS SPOUSE THAT THE PATIENT EXPERIENCED TWO STROKES WHICH THEY BELIEVE WAS CAUSED BY THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE LEADLESS IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 18483635 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THERE WAS NO PERFORMANCE ALLEGATIONS WITH THE LEADLESS IPG AND PATIENT SYMPTOMS WERE NOT RELATED TO THE PERFORMANCE OF THE LEADLESS IPG.

  Patient problems: Numbness; Pain

  MAUDE report 17973855 ↗
• InjuryOct 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN, AND A STEADY HEART RATE OVER ONE HUNDRED BEATS PER MINUTE. THE PATIENT WAS ADMINISTERED MEDICATION. THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Tachycardia

  MAUDE report 17956025 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH, COMPLETE HEART BLOCK AND CARDIOMYOPATHY BELIEVED TO BE PACING INDUCED. THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED BY A IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Heart Block

  MAUDE report 17743800 ↗
• MalfunctionSep 11, 2023Inappropriate or Unexpected Reset; Reset Problem; Inappropriate or Unexpected Reset; Reset Problem

  IT WAS FURTHER REPORTED THAT THE LEADLESS IPG EXHIBITED A PARTIAL POR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17718203 ↗
• MalfunctionJun 21, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED UNEXPECTED BATTERY DEPLETION, WITH HIGHER BATTERY DRAIN OBSERVED THAN WHAT HAD BEEN PROGRAMMED. 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 17169653 ↗
• MalfunctionJun 16, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. 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 17141871 ↗
• MalfunctionMar 22, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE INTERROGATED BY THE MONITOR. 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 16589002 ↗
• InjuryJan 24, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED CHEST PAIN AND SHINGLES. IT WAS ALSO REPORTED BY THE PATIENT THAT THEY EXPERIENCED A HEART ATTACK AND HAD A SEIZURE. IT WAS ALSO REPORTED BY THE PATIENT THAT THEY TWISTED THEIR ANKLE AND THEY WERE HOSPITALISED. THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Convulsion/Seizure; Myocardial Infarction; Viral Infection

  MAUDE report 16231817 ↗
• InjuryDec 4, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ASYSTOLIC EVENT, WITH A LONG PAUSE ON THE MONITOR. THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole

  MAUDE report 15912427 ↗
• MalfunctionNov 26, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) TRANSMISSION WAS NOT DELIVERED. 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 15866914 ↗

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.