BioMonitor IV 471155Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BIOTRONIK BioMonitor IV is an implantable cardiac event recorder. The reports most often describe devices migrating or being expelled from the implant pocket, with wound dehiscence, pocket erosion, or discomfort; some mention sensing problems. There are 80 reports naming the identifier, with no deaths and 73 injuries, plus 7 malfunctions. No FDA recall names this device. Reports rose from 24 to 46 in the last 12 months compared with the prior 12 months.
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
- 82
- Deaths reported
- 0
- Injuries reported
- 75
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 04035479177850), received between Jun 26, 2024 and Sep 25, 2026 — classified as 75 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (25 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem35
- Migration or Expulsion of Device25
- Device Sensing Problem12
- Failure to Interrogate5
- Device Dislodged or Dislocated4
- Ambient Noise Problem3
- Expulsion3
- Failure to Sense3
Patient problems
- Wound Dehiscence27
- No Clinical Signs, Symptoms or Conditions25
- Pocket Erosion10
- Discomfort8
- Unspecified Infection8
- Implant Pain6
- Anxiety1
- Erythema1
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Device was explanted per patient complaint of causing discomfort due to original placement. Should additional information be received this file will be updated.
Patient problems: Discomfort
MAUDE report 50899872 ↗InjurySep 16, 2026Migration or Expulsion of Device; Device Dislodged or Dislocated
This device dislodged and fell out through sutures. Date of migration unknown. Should additional information become available, this file will be updated.
Patient problems: Wound Dehiscence
MAUDE report 50790299 ↗InjurySep 15, 2026Migration or Expulsion of Device; Device Sensing Problem
This device was explanted due to migration resulting in loss of signal. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779022 ↗InjurySep 8, 2026Failure to Interrogate
This device was explanted due to device could not be interrogated post implant. 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 50671520 ↗InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
Device was explanted due to patient complaint of discomfort. Should additional information be received, this file will be updated.
Patient problems: Discomfort
MAUDE report 50457096 ↗InjuryAug 20, 2026Failure to Sense; Ambient Noise Problem
Device was explanted due to HMSC reported loss of sensing on recordings after (b)(6) 2026. sECG recordings appear noisy. Patient confirmed to have cardioversion on (b)(6) 2026. Device reset was unsuccessful. Signal remained in poor quality. 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 50351548 ↗InjuryAug 19, 2026Migration or Expulsion of Device
Loop recorder externalized and was partially exposed at clinic visit. Physician explanted device. Should additional information become available, this file will be updated.
Patient problems: Wound Dehiscence
MAUDE report 50329874 ↗InjuryAug 18, 2026Migration or Expulsion of Device; Device Sensing Problem
This device was explanted because it migrated and was not 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 50300015 ↗InjuryAug 6, 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 50164180 ↗InjuryAug 3, 2026Migration or Expulsion of Device
This device was reported to have fallen out of the pocket. Should additional information be received this file will be updated.
Patient problems: Wound Dehiscence
MAUDE report 50114330 ↗InjuryJul 29, 2026Migration or Expulsion of Device
This loop was explanted after hanging out of patients skin. Should additional information become available, this file will be updated.
Patient problems: Wound Dehiscence
MAUDE report 50069185 ↗InjuryJul 28, 2026Migration or Expulsion of Device; Device Dislodged or Dislocated
Device dislodged from incision while at home and migrated out of the pocket. Should additional information become available, this file will be updated.
Patient problems: Wound Dehiscence
MAUDE report 50056030 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
This device was explanted due to patient has sensitive skin and wanted loop removed. Should additional information become available, this file will be updated.
Patient problems: Discomfort
MAUDE report 50055980 ↗InjuryJun 29, 2026Device Sensing Problem
THIS DEVICE WAS EXPLANTED DUE TO LOSS OF SIGNAL FOLLOWING A 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 25654052 ↗InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem
DEVICE WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25548743 ↗InjuryJun 10, 2026Migration or Expulsion of Device
THIS DEVICE WAS EXPLANTED DUE TO IT BROKE THROUGH THE INCISION SITE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Wound Dehiscence
MAUDE report 25462783 ↗MalfunctionJun 2, 2026Migration or Expulsion of Device; Device Sensing Problem
PATIENT CAME TO THE OFFICE ON (B)(6) 2026 FOR A FOLLOW UP. THE DEVICE COULD NOT BE INTERROGATED. THE PATIENT WAS SENT FOR CHEST XRAY AND THE DEVICE COULD NOT BE SEEN ON XRAY. THE PATIENT WAS THEN SENT FOR CT SCAN. THE RESULTS OF THE CT SCAN SHOWED THAT THE DEVICE COULD NOT BE LOCATED. EVIDENCE ON HOME MONITORING SHOWS THE PATIENT IS TRANSMITTING LAST MESSAGE (B)(6) 2026 WITH THEIR OWN CARDIO MESSENGER. REVIEWING DATA SHOWS COMPLETE LOSS OF SENSING CURRENTLY. THERE ARE CONCERNS OF THE POSSIBILITY OF MIGRATION DUE TO NOT BE ABLE TO LOCATE THE DEVICE ON IMAGING. THE PATIENT CURRENTLY IS ASYMPTOMATIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364109 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
DEVICE WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25354639 ↗InjuryJun 1, 2026Migration or Expulsion of Device
IT WAS REPORTED THAT THIS DEVICE FELL OUT OF THE PATIENTS BODY. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Wound Dehiscence
MAUDE report 25354630 ↗InjuryMay 21, 2026Failure to Interrogate
THIS DEVICE WAS IMPLANTED BUT THEN WAS NOT BEING IDENTIFIED AND COULD NOT BE INTERROGATED OR PROGRAMED BY SEVERAL DIFFERENT PROGRAMMERS. THE DEVICE WAS THEN EXPLANTED AND A NEW DEVICE IMPLANTED WITH NO ISSUE. NO ADVERSE PATIENT EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25244341 ↗InjuryMay 18, 2026Device Sensing Problem
THIS DEVICE WAS EXPLANTED DUE TO LOSS OF SENSING POST CARDIOVERSION AND SUSPECTED DAMAGE. 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 25210991 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
DEVICE WAS EXPLANTED DUE TO PATIENT WANTED TO REMOVE BECAUSE HE CLAIMED THAT IT INTERFERED WITH HIS THERAPY HE WAS GETTING AND IT WAS PAINFUL.
Patient problems: Implant Pain
MAUDE report 25148553 ↗InjuryMay 4, 2026Migration or Expulsion of Device
PATIENT REPORTED A FALL WHICH RIPPED THEIR SUTURES CAUSING THE LOOP TO FALL OUT. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Fall; Wound Dehiscence
MAUDE report 25074852 ↗InjuryMay 1, 2026Migration or Expulsion of Device
IT WAS REPORTED THAT THIS DEVICE FELL OUT. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Wound Dehiscence
MAUDE report 25059599 ↗InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem
INCISION DID NOT HEAL AFTER IMPLANT AND DEVICE POKED OUT LEADING TO INFECTION AND WAS EXPLANTED.
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 25059595 ↗
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
- BioMonitor III 436066BIOTRONIK SE & Co. KG · RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITH ARRHYTHMIA DETECTION)655 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
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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