Rivacor 7 HF-T QP DF4 IS4 ProMRI 429532Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Rivacor 7 is an implantable defibrillator that delivers shocks and pacing to the heart. Its 253 reports often describe infections around the device, including blood infections and sepsis, and some describe batteries signaling replacement early, with several devices removed. The reports include 198 injuries and 5 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
- 255
- Deaths reported
- 5
- Injuries reported
- 200
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 255 adverse event reports that list this exact device (DI 04035479156770), received between Apr 23, 2019 and Sep 11, 2026 — classified as 5 deaths, 200 injuries, 50 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (31 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 Problem191
- Premature Elective Replacement Indicator31
- Premature End-of-Life Indicator13
- Battery Problem4
- Failure to Interrogate4
- High impedance3
- Migration or Expulsion of Device3
- Ambient Noise Problem2
Patient problems
- Unspecified Infection155
- No Clinical Signs, Symptoms or Conditions56
- Hematoma11
- Pocket Erosion10
- Bacteremia5
- Endocarditis5
- No Known Impact Or Consequence To Patient4
- Implant Pain3
Recent adverse event reports
The 25 most recent of 255 reports, in the reporter's own words as published by the FDA.
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 50734651 ↗InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to Vegetation noted in Echocardiogram of RV lead. Device is currently being used for temporary pacing externally. Should additional information be received, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50590834 ↗InjuryAug 19, 2026Premature 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 50322838 ↗InjuryAug 18, 2026Premature 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 50311093 ↗InjuryAug 12, 2026Premature 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 50224747 ↗InjuryAug 7, 2026Premature 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 50180299 ↗InjuryJul 6, 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 25727740 ↗MalfunctionJun 10, 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 25461958 ↗MalfunctionMay 18, 2026Premature End-of-Life Indicator
DEVICE IS AT EOS 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 25211016 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO BACTEREMIA INFECTION WITH SEPSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Bacteremia; Sepsis
MAUDE report 25177576 ↗InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO VEGETATION ON LEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25093989 ↗InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
DEVICE WAS EXPLANTED DUE TO POCKET EROSION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 25074900 ↗InjuryApr 28, 2026Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO EOS. PATIENT HAD OVER 135 MAX ENERGY SHOCKS (APPROPRIATE) WHICH DEPLETED THE BATTERY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25021846 ↗InjuryApr 16, 2026Device Sensing Problem
PATIENT HAD AN LV LEAD REVISION. REVISED LEAD PLACED WITH GOOD NUMBERS THROUGH PSA ON ALL 4 POLES. CONNECTED TO CAN AND RAN RV-LV CONDUCTION TIME TEST. RVS TO LVS NUMBERS APPEARED APPROPRIATELY. WITH RVP TO LVS ONLY POLE 1 GAVE NUMBERS. CHECKED ON FLORO AND LEAD WAS STABLE IN LATERAL POSITION ON THE HEART. MANUALLY TESTED LEADS FROM EACH POLE AND HAD GOOD CAPTURE VALUES WITH IMPEDANCES WITHIN NORMAL LIMITS. DISCONNECTED LEAD FROM CAN AND CHECKED VALUES THROUGH PSA WITH STABLE THRESHOLD AND IMP. RECONNECTED TO CAN. RVP TO LVS STILL ONLY GAVE NUMBERS FROM POLE 1. POSSIBLE HEADER ISSUE. DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24901300 ↗InjuryMar 24, 2026Premature End-of-Life 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 24675418 ↗MalfunctionMar 18, 2026Premature End-of-Life Indicator
PATIENT HAD MULTIPLE SHOCKS DELIVERED ON (B)(6) 2026 FOR ARRYTHMIAS. WHEN INTERROGATED DEVICE HAD ALERT FOR EOS. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629468 ↗InjuryMar 2, 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 24483175 ↗InjuryFeb 24, 2026Premature Elective Replacement Indicator
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 24429011 ↗InjuryFeb 23, 2026Premature End-of-Life Indicator; Inappropriate/Inadequate Shock/Stimulation
PATIENT ARRIVED AT HOSPITAL AFTER RECEIVING SHOCKS. PATIENT DID RECEIVE MORE SHOCKS AFTER ARRIVING AT THE HOSPITAL ACCORDING TO HOSPITAL STAFF. HOME MONITORING SHOWS RV LEAD MONITORING EPISODE AT 11:41 PM (B)(6) 2026. 24 SHOCKS STARTED; 14 INAPPROPRIATE SHOCKS DELIVERED FOR LEAD NOISE THAT WERE TRANSMITTED. DEVICE WAS EOS WHEN REPRESENTATIVE TRIED TO INTERROGATE AND COULD NOT SEE TOTAL NUMBER OF SHOCKS. TRANSMISSION FROM EARLY MORNING (B)(6) 2026 TO HOME MONITORING STILL SHOWED 55 PERCENT BATTERY LIFE. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24413820 ↗InjuryFeb 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 24371675 ↗MalfunctionFeb 9, 2026Premature Elective Replacement Indicator
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 24299946 ↗InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO BACTEREMIA INFECTION. PATIENT WAS ADMITTED (B)(6) 2026, IS STILL HOSPITALIZED, AND ALSO HAS LVAD AND WOUND VAC. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED
Patient problems: Bacteremia
MAUDE report 24185391 ↗InjuryJan 26, 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: Bacteremia
MAUDE report 24185297 ↗InjuryJan 15, 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 24085003 ↗InjuryDec 29, 2025Battery Problem; 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 23905779 ↗
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.
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