Acticor 7 HF-T DF4 IS-1 ProMRI 429523Recalls & 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 HF-T is an implanted defibrillator with heart resynchronization. The 70 reports mostly describe the unit being removed (explanted) because of infection at the implant site, along with pocket erosion and a hematoma that wouldn't heal; there are 53 injuries and no deaths. Some reports also note the device reaching end-of-service status sooner than expected or failing to be read during a check. 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
- 73
- Deaths reported
- 0
- Injuries reported
- 56
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 04035479156688), received between Jan 10, 2020 and Sep 16, 2026 — classified as 56 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (9 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 Problem53
- Premature Elective Replacement Indicator9
- Premature End-of-Life Indicator3
- Ambient Noise Problem2
- Failure to Interrogate2
- Inappropriate/Inadequate Shock/Stimulation2
- Device Sensing Problem1
- Failure to Capture1
Patient problems
- Unspecified Infection41
- No Clinical Signs, Symptoms or Conditions18
- Hematoma4
- Pocket Erosion4
- Bradycardia1
- Discomfort1
- Drug Resistant Bacterial Infection1
- Fever1
Recent adverse event reports
The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Premature End-of-Life Indicator
This device was explanted due to EOS after approximately 65 appropriate shocks since (b)(6) 2026 (patient was out of the country). Should additional information become available, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782711 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
After successful implantation of this device, a Medtronic Spere 9 was used to ablate the AV node via RF. The first burn was successful. The second burn resulted in inducing the patient into VF. The patient was restored to sinus rhythm after external defibrillation. Device remains implanted.
Patient problems: Ventricular Fibrillation
MAUDE report 50557235 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
System explanted due to pocket erosion. Should additional information be received, this file will be updated.
Patient problems: Pocket Erosion
MAUDE report 50278178 ↗InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to non-healing hematoma. Should additional information become available, this file will be updated.
Patient problems: Hematoma
MAUDE report 50213809 ↗InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to lead vegetation. Should additional information become available, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50134482 ↗InjuryJun 10, 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 25457457 ↗InjuryApr 27, 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 25000675 ↗MalfunctionApr 13, 2026Premature End-of-Life Indicator
DEVICE WAS PUT INTO AUTO MRI MODE FOR A SCAN AND THE SESSION WAS ENDED WITHOUT ISSUE. TWO DAYS LATER, A FACILITY CLINICIAN INTERROGATED THE DEVICE AND REPORTED THE DEVICE IS EOS. 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 24860578 ↗InjuryMar 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 24573469 ↗InjuryJan 22, 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 24151014 ↗InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24133678 ↗InjuryJan 12, 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 24042713 ↗InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
POCKET REVISION/EVACUATION DUE TO HEMATOMA. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Hematoma
MAUDE report 23910895 ↗InjuryDec 2, 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 23694332 ↗MalfunctionNov 18, 2025Premature 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 23586483 ↗InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO POCKET EROSION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 23568860 ↗InjurySep 4, 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 22965753 ↗InjuryAug 25, 2025Migration or Expulsion of Device; Migration or Expulsion of Device
DEVICE CHANGED AT TIME OF POCKET REVISION DUE TO MIGRATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22882988 ↗InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 22788065 ↗MalfunctionAug 11, 2025Ambient Noise Problem; Ambient Noise Problem
DEVICE EXHIBITED NOISE ON RV LEAD AFTER NEW RV LEAD WAS IMPLANTED. PHYSICIAN WAS IN A HURRY AND ADEQUATE TIME FOR TROUBLE-SHOOTING WAS NOT PRACTICAL. PHYSICIAN ASKED FOR NEW DEVICE, SO THIS ONE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771097 ↗InjuryJul 30, 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 22670123 ↗MalfunctionJul 30, 2025Premature End-of-Life Indicator; Inappropriate/Inadequate Shock/Stimulation; Premature End-of-Life Indicator; Inappropriate/Inadequate Shock/Stimulation
THIS DEVICE WAS EXPLANTED DUE TO EOS, POSSIBLY DUE TO 40 PLUS INAPPROPRIATE SHOCKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22669288 ↗InjuryJul 30, 2025Adverse 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 22666427 ↗MalfunctionJul 22, 2025Premature 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 22568654 ↗MalfunctionJul 17, 2025Premature 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 22538524 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 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