Micra™ MC1VR01US (UDI 00643169711761)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,106 adverse event reports that list this exact device (DI 00643169711761), received between Apr 20, 2018 and Sep 29, 2026 — classified as 157 deaths, 803 injuries, 1,146 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (494 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 2,106 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjurySep 15, 2026Appropriate Device Problem Term/Code Not Available

  It was reported by the patient representative that the Leadless implantable pulse generator (IPG) was removed and replaced as it was not working properly. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769376 ↗
• MalfunctionAug 20, 2026Pacing Problem

  It was reported that the patient experienced bradycardia with heart rates in the thirties which is lower than the Leadless implantable pulse generator's (IPG) 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 50350674 ↗
• MalfunctionAug 19, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325624 ↗
• MalfunctionAug 12, 2026Signal Artifact/Noise; Over-Sensing

  It was further reported that the Leadless IPG was reprogrammed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218233 ↗
• InjuryJul 29, 2026Pacing Problem

  It was reported that the patient experienced syncope and heart rate was at 47-74 beats per minute. The Leadless implantable pulse generator (IPG) was pacing below the programmed lower limit. The device remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Syncope/Fainting

  MAUDE report 50077642 ↗
• InjuryJun 26, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED HIGH THRESHOLDS. THE DEVICE WAS INACTIVATED AND REPLACED WITH A NEW TRANSVENOUS SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25632977 ↗
• MalfunctionMay 27, 2026Electrical /Electronic Property Problem; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED VENTRICULAR UNDERSENSING OBSERVED ON PRESENTING EGM RESULTING IN INAPPROPRIATE PACING. A  SHOCKING OR BUZZING SENSATION WAS ALSO REPORTED BY THE PATIENT. 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 25299437 ↗
• MalfunctionMay 27, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT HAD A VARIED HEART RATE. THEY REPORT THAT THE PATIENT REPORTS THEIR HEART RATE WAS IN THE THIRTIES. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 25298666 ↗
• InjuryMay 20, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) HAD BATTERY DEPLETION. ON FURTHER REVIEW, THERE WAS NO BATTERY DEPLETION NOTED ON THE DEVICE. THE BATTERY LONGEVITY WAS AS EXPECTED AND BATTERY HAD APPROPRIATE BATTERY DEPLETION FOR THE HIGH OUTPUTS PROGRAMMED INITIALLY. IT WAS FURTHER REPORTED THAT THE LEADLESS IPG WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25226777 ↗
• MalfunctionMay 18, 2026High Capture Threshold

  IT WAS REPORTED THAT LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED HIGH THRESHOLDS. THE DEVICE REMAINS IN USE. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25199630 ↗
• MalfunctionMay 15, 2026Failure to Interrogate

  IT WAS REPORTED THAT THERE WAS A READER POSITION AND CONNECTIVITY ISSUE WITH MYCARELINK FOR A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), WITH NO TELEMETRY OBTAINED. A CLINICIAN CALLED AND STATED THE PATIENT NEEDED ASSISTANCE WITH THE MONITOR. TROUBLESHOOTING WAS PERFORMED USING STEPS 1¿2 AND ADDITIONAL STEPS A¿C FOR READER POSITION/NO TELEMETRY WITH MYCARELINK, AND THE PROGRESS BAR WAS REPORTED AS NOT FILLING DURING TROUBLESHOOTING. THE PATIENT WAS REFERRED TO THE CLINIC. 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 25183287 ↗
• InjuryApr 27, 2026Premature Discharge of Battery; High Capture Threshold

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION DUE TO PASSIBLE HIGH THRESHOLDS. 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 24995200 ↗
• MalfunctionApr 8, 2026Failure to Interrogate

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A READER POSITION ISSUE WITH NO TELEMETRY WHEN ATTEMPTING TO SET UP A REMOTE MONITOR FOR A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT CALLED FOR ASSISTANCE AFTER RECEIVING THE NEW MONITOR TWO DAYS PRIOR AND WAS UNABLE TO SUCCESSFULLY COMPLETE THE MONITOR SETUP, AS THE PROGRESS BAR DID NOT FILL AND TRANSMISSION WAS NOT SUCCESSFUL. TROUBLESHOOTING STEPS INCLUDED ADJUSTING THE MONITOR POSITION, POWER CYCLING THE MONITOR, PLACING A DRY WASHCLOTH BETWEEN THE READER AND THE IMPLANT, REMOVING POSSIBLE INTERFERENCE WITHIN SIX FEET, AND ATTEMPTING TRANSMISSION IN ANOTHER ROOM, BUT ALL ATTEMPTS WERE UNSUCCESSFUL. THE PATIENT WAS REFERRED TO THE CLINIC. 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 24815579 ↗
• MalfunctionApr 7, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) "STOPPED WORKING". THE LEADLESS IPG REMAINS IN USE. NO PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24798667 ↗
• InjuryMar 30, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE 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 24712718 ↗
• MalfunctionMar 16, 2026Failure to Interrogate

  IT WAS REPORTED THAT DURING THE SETUP OF A NEW MONITOR FOR A PACEMAKER, THERE WAS A READER POSITION ISSUE RESULTING IN NO TELEMETRY WITH MYCARELINK. TROUBLESHOOTING STEPS PER PRODUCT LABELLING WAS FOLLOWED. IT WAS ALSO REPORTED THAT THE LEADLESS IMPLANTABLE PULSEGENERATOR (IPG) EXHIBITED NO TELEMETRY. THE ISSUE WAS REFERRED TO THE CLINIC. 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 24606820 ↗
• MalfunctionMar 3, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT WHILE ATTEMPTING TO SEND A TRANSMISSION WITH THE NEW READER FOR A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), BEEPING SOUNDS WERE HEARD ON THE REMOTE MONITOR. A GREEN BAR APPEARED FOR SEVERAL SECONDS AND THEN DISAPPEARED, AND THE TRANSMISSION COULD NOT BE SENT. THE READER WAS CHARGED FOR ONE HOUR, THE MONITOR WAS POWERCYCLED, A DRY WASHCLOTH WAS USED, THE READER WAS MOVEDIN CIRCLES OVER THE CHEST, AND THE ATTEMPT WAS MADE IN A DIFFERENT ROOM WITH A GOOD CELLULAR SIGNAL. FOUR ATTEMPTS WERE MADE, BUT THE TRANSMISSION COULD NOT BE SENT. THE PATIENT WAS ADVISED TO SET AN APPOINTMENT WITH THE CLINIC TO CHECK THE DEVICE. THERE WAS NO TELEMETRY ON THE LEADLESS IPG. 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 24496246 ↗
• MalfunctionMar 3, 2026Pacing Problem

  IT WAS REPORTED THAT A PATIENT WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED A SERIES OF CARDIAC EVENTS INCLUDING ATRIAL FIBRILLATION, TACHYCARDIA, BRADYCARDIA WITH HEART RATES DETECTED BELOW 60 BEATS PER MINUTE (BPM) (INCLUDING READINGS IN THE 40S AND 50S, A PULSE OXIMETER RESULT OF 38, AND A MANUAL PULSE CHECK OF 48). THE PATIENT NOTED THAT THE DEVICE WAS NOT MAINTAINING THE PROGRAMMED LOWER RATE OF 60 BPM, WITH EVIDENCE FROM DEVICE READINGS AND PERSONAL MONITORING INDICATING HEART RATES BELOW THE INTENDED THRESHOLD ON SEVERAL OCCASIONS, PARTICULARLY AT NIGHT. THE PATIENT SUGGESTED THAT POSSIBLE INADEQUATE NUTRITION DUE TO DIETING MAY HAVE CONTRIBUTED TO THE ARRHYTHMIAS. THE LEADLESS IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Bradycardia; Tachycardia

  MAUDE report 24493906 ↗
• InjuryJan 20, 2026Premature Discharge of Battery; High Capture Threshold

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION DUE TO NEAR 100% PACING AND ELEVATED THRESHOLD. 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 24113749 ↗
• MalfunctionJan 19, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION. 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 24107795 ↗
• MalfunctionJan 15, 2026Reset Problem

  IT WAS REPORTED THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED AND ELECTRICAL RESET. 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 24078129 ↗
• DeathJan 6, 2026Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT DIED AFTER CODING. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED DIZZINESS, AND THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NON-CAPTURE AND PACING BELOW THE RATE SETTING.

  Patient problems: Cardiac Arrest; Dizziness

  MAUDE report 23973209 ↗
• MalfunctionJan 5, 2026Over-Sensing

  IT WAS REPORTED THAT THE DEVICE EXHIBITED T-WAVE OVERSENSING (TWOS) POST VENTRICULAR PACING. 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 23955754 ↗
• InjuryDec 17, 2025Premature Discharge of Battery; Premature 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 23826706 ↗

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.