BioMonitor 2-AF 398493Recalls & 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 2-AF is an implantable heart monitor that records heart rhythms. Its 151 adverse event reports include 90 injuries and no deaths, and many describe unusual battery behavior, devices shifting, pain, and infections; many devices were removed. 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
- 151
- Deaths reported
- 0
- Injuries reported
- 90
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 04035479135522), received between Jun 15, 2018 and Jul 6, 2026 — classified as 90 injuries, 61 malfunctions.
The most frequently reported specific device problem is “Failure to Interrogate” (18 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 Problem79
- Failure to Interrogate18
- Premature Elective Replacement Indicator17
- Battery Problem12
- Migration or Expulsion of Device9
- Device Sensing Problem7
- Ambient Noise Problem4
- Migration4
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Known Impact Or Consequence To Patient31
- Unspecified Infection29
- Discomfort25
- Pain13
- Pocket Erosion10
- Implant Pain8
- Wound Dehiscence7
Recent adverse event reports
The 25 most recent of 151 reports, in the reporter's own words as published by the FDA.
InjuryJul 6, 2026Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED DUE TO ERI WITH UNUSUAL BATTERY BEHAVIOR. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25724718 ↗MalfunctionMay 5, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO EOS. 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 21961340 ↗InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO PATIENT COMPLAINT OF PAIN AT IMPLANT SITE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Implant Pain
MAUDE report 21688017 ↗MalfunctionDec 10, 2024Premature 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 20899252 ↗InjuryJul 9, 2024Migration; Migration
LOOP WAS EXPLANTED AND REIMPLANTED ON (B)(6) 2017, APPROXIMATELY 10 DAYS AFTER IMPLANT. LOOP HAD MIGRATED AROUND LEFT BREAST IMPLANT OF PT. WITHOUT ANY PHYSICAL MANIPULATION BY PATIENT. THIS CAUSED SIGNIFICANT PHYSICAL DISCOMFORT TO PATIENT. ON (B)(6) 2024 LOOP WAS EXPLANTED DUE TO ERI. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Discomfort
MAUDE report 19703224 ↗MalfunctionMar 22, 2024Premature 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 18960711 ↗MalfunctionDec 12, 2023Failure to Sense; Ambient Noise Problem; Failure to Sense; Ambient Noise Problem
LOOP WAS EXPLANTED DUE TO LOSS OF SENSING AND NOISE. PATIENT REPORTED A CARDIOVERSION ON 29-SEPT-2023. 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 18311568 ↗MalfunctionNov 28, 2023Battery Problem; Battery Problem
DEVICE WAS EXPLANTED DUE TO UNEXPECTED 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 18222945 ↗InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 17424327 ↗InjuryJun 20, 2023Migration or Expulsion of Device; Migration or Expulsion of Device
DEVICE WAS EXPLANTED DUE TO MIGRATION AND PAIN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Implant Pain; Wound Dehiscence
MAUDE report 17162697 ↗InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO PATIENT COMPLAINT OF DISCOMFORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Discomfort
MAUDE report 16947179 ↗MalfunctionMay 16, 2023Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH UNEXPECTED BATTERY BEHAVIOR BASED ON DEVICE ANALYSIS. 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 16942919 ↗InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE WAS EXPLANTED DUE TO PATIENT COMPLAINT OF PAIN AND DISCOMFORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Implant Pain
MAUDE report 16904160 ↗InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS REMOVED AT PATIENT REQUEST DUE TO COMPLAINT OF DISCOMFORT.
Patient problems: Discomfort
MAUDE report 16526089 ↗InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO PATIENT COMPLAINT OF PAIN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Implant Pain
MAUDE report 16023487 ↗MalfunctionOct 13, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED DUE TO BATTERY ERROR MESSAGE AND 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 15595059 ↗InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS BIOMONITOR 2 AF WAS EXPLANTED DUE TO PATIENT COMPLAINT OF PAIN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Implant Pain
MAUDE report 15335025 ↗InjuryAug 18, 2022Migration or Expulsion of Device; Migration or Expulsion of Device
DEVICE EXPLANTED DUE TO MIGRATION CAUSING DISCOMFORT TO THE PATIENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Wound Dehiscence
MAUDE report 15254913 ↗MalfunctionAug 9, 2022Premature 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 15192450 ↗MalfunctionAug 3, 2022Battery Problem; Battery Problem
DEVICE HIT ERI ON (B)(6) 2020. DEVICE EXPLANTED (B)(6) 2022. BASED ON THE ANALYSIS, REPORTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15158096 ↗MalfunctionJun 17, 2022Failure to Interrogate; Failure to Interrogate
THIS DEVICE WAS EXPLANTED DUE TO IT COULD NOT BE INTERROGATED. 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 14732584 ↗MalfunctionMay 10, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO 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 14349551 ↗InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE EXPLANTED DUE TO SEPSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Sepsis
MAUDE report 13778525 ↗MalfunctionFeb 18, 2022Failure to Interrogate; Premature Elective Replacement Indicator; Failure to Interrogate; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI AND FAILURE TO INTERROGATE. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13559404 ↗MalfunctionJan 24, 2022Failure to Interrogate; Failure to Interrogate
DEVICE EXPLANTED DUE TO FAILURE TO INTERROGATE AND DEVICE NOT TRANSMITTING TO HOME MONITORING. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13338000 ↗
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
- 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 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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