Ilesto 5 VR-T DF4 383584Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04035479125400), received between May 19, 2021 and Apr 13, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (3 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.
Most reported problems
Device problems
- Premature Elective Replacement Indicator3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
(B)(6) 2022, ERI ALERT WAS RECEIVED AT THE HOSPITAL. IT WAS REPORTED THAT ABOUT 45 PERCENT OF THE BATTERY REMAINED IN (B)(6) 2021. THE DEVICE IS SCHEDULED FOR REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14103628 ↗MalfunctionOct 19, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED DUE TO ERI.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12656279 ↗MalfunctionMay 19, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THE HM DATA SHOWED EARLY ERI. PLEASE NOTE THIS ICD IS AFFECTED BY A FIELD SAFETY CORRECTIVE ACTION, BIO-LQC, INITIATED IN (B)(6) 2021.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11848928 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page