Ilesto 7 VR-T DF-1 US 383578Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BIOTRONIK Ilesto 7 VR-T is an implantable defibrillator, a device placed in the body to keep the heart from beating in an abnormal rhythm. Most of the 28 reports describe units signaling that the battery had reached end of life sooner than expected, prompting doctors to remove and replace them; a few also mention the device not reading out properly. Two injuries were reported and no deaths. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 04035479125349), received between Apr 3, 2019 and Dec 19, 2025 — classified as 2 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (12 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 Indicator12
- Premature End-of-Life Indicator11
- Battery Problem4
- Failure to Interrogate2
- Adverse Event Without Identified Device or Use Problem1
- Unable to Obtain Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Known Impact Or Consequence To Patient7
- Pocket Erosion1
- Shock from Patient Lead(s)1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 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 23849642 ↗MalfunctionNov 17, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE EXPLANTED DUE TO EOS 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 23568980 ↗MalfunctionJun 11, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO EOS 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 22185133 ↗MalfunctionMar 10, 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 21568983 ↗MalfunctionDec 5, 2024Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE EXPLANTED DUE TO EOS. 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 20854641 ↗MalfunctionNov 11, 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 20660233 ↗MalfunctionOct 7, 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 20392270 ↗MalfunctionAug 22, 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 20031607 ↗MalfunctionJun 18, 2024Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE WAS INTERROGATED ON (B)(6) 2024 AND WAS FOUND TO BE IN EOS. DEVICE CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19558584 ↗InjuryJul 26, 2023Premature End-of-Life Indicator; Premature End-of-Life Indicator
PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO NOISE ON THE ASSOCIATED RV LEAD. PATIENT WENT TO THE ER WHERE DEVICE WAS INTERROGATED AND FOUND TO BE EOS. DEVICE CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 17400856 ↗MalfunctionMar 1, 2023Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE SHOWS ERI WITH UNEXPECTED BATTERY BEHAVIOR. DEVICE 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 16464900 ↗MalfunctionFeb 21, 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 16414421 ↗MalfunctionDec 13, 2022Premature 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 15971910 ↗MalfunctionJun 6, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE AT 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 14604975 ↗MalfunctionMay 13, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE IS AT ERI INDICATION WITH UNEXPECTED BATTERY BEHAVIOR. DEVICE CURRENTLY 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 14401742 ↗MalfunctionOct 11, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED. ERI REPORTED ON HM WITH BATTERY VOLTAGE 3.02. 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 12608423 ↗MalfunctionAug 18, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE SHOWED 53 PERCENT BATTERY LONGEVITY ON 25-SEP-2020, AND AN ERI ALERT ON (B)(6) 2020. DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. THE DEVICE ANALYSIS INDICATED A BATTERY ISSUE. NO ADVERSE PATIENT EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12339895 ↗MalfunctionJul 29, 2021Failure to Interrogate; Premature End-of-Life Indicator; Failure to Interrogate; Premature End-of-Life Indicator
DEVICE REMAINS IMPLANTED. DEVICE APPEARS TO BE AT EOS AND IS NOT RESPONDING TO INTERROGATION. DEVICE WILL BE CHANGED OUT AS SOON AS POSSIBLE. 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 12244916 ↗MalfunctionJul 19, 2021Failure to Interrogate; Failure to Interrogate
DEVICE IS NOT ABLE TO BE INTERROGATED. THE PATIENT SHOWED UP TO THE ER AFTER RECEIVING MULTIPLE SHOCKS AND AFTER THAT THE DEVICE WAS NOT ABLE TO BE INTERROGATED. IT WAS RECOMMENDED TO CHANGE OUT THE DEVICE. DEVICE EXPLANTED ON (B)(6) 2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12193524 ↗MalfunctionJun 7, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE AT ERI WITH UNEXPECTED BATTERY BEHAVIOR. THE DEVICE REMAINS IMPLANTED AT THIS TIME. NO ADVERSE PATIENT EVENTS HAVE BEEN REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11946445 ↗MalfunctionAug 27, 2020Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE EXPLANTED DUE TO EOS. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10460754 ↗MalfunctionMay 13, 2020Battery Problem; Battery Problem
(B)(6), DEVICE SHOWED 77 PERCENT BATTERY ONE MONTH AGO. TODAY ON HOME MONITORING AND AN IN OFFICE CHECK THE DEVICE IS AT ERI. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) AND RETURNED FOR ANALYSIS. 5/13/2020, BASED ON THE ANALYSIS, THIS IS REPORTABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10052106 ↗MalfunctionFeb 18, 2020Unable to Obtain Readings; Unable to Obtain Readings
THIS DEVICE WAS UNABLE TO BE INTERROGATED (B)(6) 2020 OR (B)(6) 2020. DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9723624 ↗InjuryFeb 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO EROSION. NEW UPGRADED SYSTEM WAS IMPLANTED SAME DAY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED. HOSPITAL RETAINED SYSTEM AND SHOULD RETURN IT FOR ANALYSIS.
Patient problems: Pocket Erosion
MAUDE report 9717470 ↗MalfunctionSep 18, 2019Premature Elective Replacement Indicator; Battery Problem; Premature Elective Replacement Indicator; Battery Problem
THIS DEVICE REPORTED ERI STATUS ON (B)(6) 2019. IN (B)(6) OF 2018, IN OFFICE INTERROGATION SHOWED BATTERY LONGEVITY OF 85%. THE DEVICE WAS EXPLANTED ON (B)(6) 2019 DUE TO ERI. BASED ON THE ANALYSIS RESULTS RECEIVED FROM THE MANUFACTURER ON (B)(4) 2019, THIS EVENT IS REPORTABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9082633 ↗
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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