Acticor 7 VR-T DX DF4 ProMRI 429525Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Acticor 7 heart defibrillator has 533 adverse event reports, with 6 deaths and 400 injuries. Many reports describe infections around the implanted system, often leading to its removal, and others describe an early battery warning. 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
- 550
- Deaths reported
- 6
- Injuries reported
- 411
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 550 adverse event reports that list this exact device (DI 04035479156701), received between Aug 9, 2019 and Sep 30, 2026 — classified as 6 deaths, 411 injuries, 133 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (94 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 Problem382
- Premature Elective Replacement Indicator94
- Premature End-of-Life Indicator30
- Battery Problem18
- Failure to Interrogate11
- Ambient Noise Problem5
- Inappropriate/Inadequate Shock/Stimulation5
- Failure to Convert Rhythm3
Patient problems
- Unspecified Infection331
- No Clinical Signs, Symptoms or Conditions150
- Ventricular Fibrillation13
- Sepsis11
- Pocket Erosion10
- Bacteremia8
- Wound Dehiscence7
- Hematoma6
Recent adverse event reports
The 25 most recent of 550 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Premature Elective Replacement Indicator; Battery Problem
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 50946704 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50926792 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50926764 ↗MalfunctionSep 25, 2026Premature Elective Replacement Indicator; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50905336 ↗InjurySep 25, 2026Premature End-of-Life Indicator
This device was explanted due to EOS as a result of multiple inappropriate shocks delivered. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899333 ↗MalfunctionSep 23, 2026Premature Elective Replacement Indicator; Battery Problem
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 50870679 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
This device was explanted due to infection. Should additional information become available, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50870678 ↗MalfunctionSep 19, 2026Premature Elective Replacement Indicator; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833651 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50796417 ↗MalfunctionSep 16, 2026Premature Elective Replacement Indicator; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795338 ↗InjurySep 16, 2026Adverse 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 50788816 ↗InjurySep 16, 2026Adverse 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 50788377 ↗MalfunctionSep 16, 2026Premature Elective Replacement Indicator; Battery Problem
Device is at ERI indication with unexpected battery behavior. No adverse patient events were reported. Device currently remains implanted. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788088 ↗MalfunctionSep 15, 2026Premature Elective Replacement Indicator; Battery Problem
Device is at ERI indication with unexpected battery behavior. No adverse patient events were reported. Device currently remains implanted. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778822 ↗InjurySep 11, 2026Adverse 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 50734227 ↗InjurySep 10, 2026Premature End-of-Life Indicator; Inappropriate/Inadequate Shock/Stimulation; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724889 ↗MalfunctionSep 3, 2026Premature Elective Replacement Indicator; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50586045 ↗InjurySep 3, 2026Adverse 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 50586044 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50569236 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
During left sided AF ablation, RF induced VT. The VT self terminated and the case was finished with PFA. Device remains implanted
Patient problems: Ventricular Fibrillation
MAUDE report 50566393 ↗InjurySep 1, 2026Adverse 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 50554022 ↗InjuryAug 25, 2026Adverse 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 50439678 ↗MalfunctionAug 18, 2026Premature Elective Replacement Indicator; Battery Problem
Device is at ERI indication with unexpected battery behavior. No adverse patient events were reported. Device currently remains implanted. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311425 ↗MalfunctionAug 18, 2026Premature Elective Replacement Indicator; Battery Problem
Device is at ERI indication with unexpected battery behavior. No adverse patient events were reported. Device currently remains implanted. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311094 ↗InjuryAug 17, 2026Adverse 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 50278971 ↗
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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