Iforia 7 VR-T DX DF-1 US 390090Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Iforia 7 VR-T DX defibrillator is implanted under the skin to monitor and correct abnormal heart rhythms. The 71 reports mostly describe units reaching the end of their service life or showing battery problems sooner than expected, prompting removal, along with a few cases where the device could not be read during a checkup; 10 reports involved injuries and no deaths were reported. 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
- 71
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 04035479127176), received between Nov 8, 2018 and Aug 25, 2025 — classified as 10 injuries, 61 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (33 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
- Premature Elective Replacement Indicator33
- Premature End-of-Life Indicator18
- Adverse Event Without Identified Device or Use Problem8
- Battery Problem5
- Failure to Interrogate3
- Premature Discharge of Battery2
- High impedance1
- Inappropriate/Inadequate Shock/Stimulation1
Patient problems
- No Clinical Signs, Symptoms or Conditions50
- No Known Impact Or Consequence To Patient12
- Unspecified Infection8
- Shock from Patient Lead(s)1
Recent adverse event reports
The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 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 22890627 ↗MalfunctionJul 30, 2025Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH 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 22664137 ↗MalfunctionJun 16, 2025Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH 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 22214972 ↗MalfunctionJun 3, 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 22132451 ↗InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 21912639 ↗MalfunctionApr 1, 2025Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH 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 21738326 ↗MalfunctionFeb 10, 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 21351650 ↗MalfunctionJan 27, 2025Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH 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 21249205 ↗InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 21182442 ↗MalfunctionJan 7, 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 21093350 ↗InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 21079712 ↗MalfunctionOct 16, 2024Interrogation Problem; Interrogation Problem
DEVICE COULD NOT BE INTERROGATED AND PATIENT WAS LOST TO FOLLOW-UP. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20468097 ↗MalfunctionOct 9, 2024Premature 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 20406307 ↗MalfunctionAug 8, 2024Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH 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 19945150 ↗MalfunctionJun 20, 2024Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH 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 19575431 ↗MalfunctionApr 29, 2024Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH 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 19210046 ↗MalfunctionJan 22, 2024Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO ERI STATUS. 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 18553336 ↗InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 18265666 ↗MalfunctionOct 25, 2023Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH 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 18003287 ↗MalfunctionOct 18, 2023Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE AT ERI INDICATION WITH UNEXPECTED BATTERY BEHAVIOR. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17956672 ↗MalfunctionSep 7, 2023Failure to Interrogate; Failure to Interrogate
DEVICE WILL NOT INTERROGATE POST LVAD PLACEMENT. DEVICE REMAINS IMPLANTED. 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 17701603 ↗MalfunctionJun 27, 2023Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH 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 17213576 ↗MalfunctionJun 20, 2023Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI INDICATION WITH 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 17162701 ↗MalfunctionMay 15, 2023Battery Problem; Battery Problem
DEVICE 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 16936633 ↗MalfunctionMay 15, 2023Premature 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 16936359 ↗
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 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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