BioMonitor III 436066Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 2 · Implant
Quick summary
This Biotronik BioMonitor III is an implantable heart monitor. Its 655 reports mostly describe the device moving out of place, being hard to find for removal, or losing its ability to sense heart signals. The reports include 339 injuries and no deaths, and they fell from 48 in the previous 12 months to 22 in the last 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 655
- Deaths reported
- 0
- Injuries reported
- 339
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 655 adverse event reports that list this exact device (DI 04035479158453), received between Aug 22, 2019 and Sep 28, 2026 — classified as 339 injuries, 316 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (147 reports).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem192
- Migration or Expulsion of Device147
- Failure to Interrogate79
- Device Sensing Problem66
- Premature Elective Replacement Indicator49
- Ambient Noise Problem43
- Failure to Sense35
- Under-Sensing23
Patient problems
- No Clinical Signs, Symptoms or Conditions301
- Wound Dehiscence100
- Pocket Erosion60
- Unspecified Infection50
- Implant Pain48
- Discomfort47
- No Known Impact Or Consequence To Patient43
- Pain10
Recent adverse event reports
The 25 most recent of 655 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Battery Problem
This device was explanted due to unusual battery behavior. No adverse patient events were reported. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916034 ↗InjurySep 19, 2026Migration or Expulsion of Device
Patient problems: Wound Dehiscence
MAUDE report 50833648 ↗InjuryAug 12, 2026Migration
Loop at normal ERI needed fluoroscopy to locate for extraction due to migration. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221279 ↗InjuryJun 3, 2026Battery Problem
THIS DEVICE WAS EXPLANTED DUE TO ERI WITH UNEXPECTED BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25375233 ↗InjuryMay 12, 2026Failure to Interrogate
THIS DEVICE WAS EXPLANTED DUE TO UNABLE TO INTERROGATE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25148557 ↗InjuryMay 7, 2026Premature Elective Replacement Indicator
LOOP WAS EXPLANTED DUE TO SUDDEN ERI AND PT HAD EXPERIENCED DISCOMFORT OF BURNING, TINGLING, AND TUGGING SENSATION IN THE PAST WHICH HAD RESOLVED AT TIME OF EXPLANT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Discomfort; Skin Burning Sensation
MAUDE report 25114154 ↗InjuryApr 22, 2026Device Sensing Problem
DEVICE WAS EXPLANTED DUE TO LOSS OF SENSING FOLLOWING CARDIOVERSION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953165 ↗InjuryApr 21, 2026Device Sensing Problem
THIS DEVICE WAS EXPLANTED DUE TO LOSS OF SENSING POST CARDIOVERSION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24941559 ↗InjuryMar 18, 2026Failure to Capture
LOOP WAS EXPLANTED DUE TO LOSS OF CAPTURE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24634292 ↗InjuryMar 16, 2026Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED DUE TO ERI WITH UNUSUAL BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24604212 ↗InjuryMar 6, 2026Failure to Interrogate
THIS DEVICE WAS EXPLANTED DUE TO WNI. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24537912 ↗InjuryFeb 24, 2026Failure to Sense
LOOP WAS EXPLANTED DUE TO NO SENSING. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24435247 ↗InjuryFeb 23, 2026Battery Problem
DEVICE EXPLANTED DUE TO UNEXPECTED DROP IN BATTERY AND UPGRADE TO CRT DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24416819 ↗InjuryFeb 11, 2026Battery Problem
THIS DEVICE WAS EXPLANTED DUE TO UNEXPECTED BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24318253 ↗InjuryJan 30, 2026Ambient Noise Problem
THIS DEVICE WAS EXPLANTED DUE TO NOISE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24223437 ↗InjuryJan 30, 2026Failure to Interrogate; Battery Problem
THIS DEVICE WAS EXPLANTED DUE TO UNEXPECTED BATTERY BEHAVIOR AND FAILURE TO INTERROGATE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24220920 ↗InjuryJan 27, 2026Peeled/Delaminated; Insufficient Device Problem Information
FRACTAL COATING/SILICONE CASING DELAMINATED AND FELL APART UPON EXPLANT, REQUIRING CLINICIAN TO DIG PIECES OF THE COATING OUT OF THE PATIENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24188755 ↗MalfunctionJan 22, 2026Premature End-of-Life Indicator
THIS DEVICE SHOWS EOS. DEVICE WAS REPLACED, BUT REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24151351 ↗MalfunctionDec 8, 2025Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED DUE TO ERI. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23746031 ↗MalfunctionNov 25, 2025Failure to Interrogate; Failure to Interrogate
THIS DEVICE WAS EXPLANTED DUE TO UNABLE TO INTERROGATE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23647769 ↗MalfunctionNov 14, 2025Failure to Sense; Failure to Sense
THIS DEVICE WAS EXPLANTED DUE TO IT STOPPED WORKING POST CARDIOVERSION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23560068 ↗MalfunctionNov 6, 2025Failure to Interrogate; Premature Elective Replacement Indicator; Failure to Interrogate; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED DUE TO FAILURE TO INTERROGATE AND ERI. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23492704 ↗InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO PATIENT DISCOMFORT AND PATIENT REQUESTED IT BE REMOVED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Discomfort
MAUDE report 23398105 ↗MalfunctionOct 27, 2025Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED DUE TO ERI WITH UNEXPECTED BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23397772 ↗MalfunctionSep 17, 2025Device Sensing Problem; Device Sensing Problem
THIS DEVICE WAS EXPLANTED DUE TO IT WAS NOT SENSING. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23076371 ↗
Other RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITH ARRHYTHMIA DETECTION) devices
- LINQ II™ LNQ22Medtronic, Inc. · Recorder, event, implantable cardiac, (with arrhythmia detection)2 recalls5,709 reports
- LINQ II™ LNQ22Medtronic, Inc. · Recorder, event, implantable cardiac, (with arrhythmia detection)1 recall1,228 reports
- LUX-Dx II+™ 60M312-100Boston Scientific Corporation · Recorder, event, implantable cardiac, (with arrhythmia detection)1 recall429 reports
- LUX-Dx™ Insertable Cardiac Monitor M301Boston Scientific Corporation · Recorder, event, implantable cardiac, (with arrhythmia detection)478 reports
- BioMonitor IIIm 450218BIOTRONIK SE & Co. KG · Recorder, event, implantable cardiac, (with arrhythmia detection)373 reports
- BioMonitor 2-AF 398493BIOTRONIK SE & Co. KG · RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITH ARRHYTHMIA DETECTION)151 reports
- LUX-Dx II™ 60M302-100Boston Scientific Corporation · Recorder, event, implantable cardiac, (with arrhythmia detection)1 recall77 reports
- BioMonitor IV 471155BIOTRONIK SE & Co. KG · Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)82 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.