Evia HF-T 377208Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 1
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04035479118372), received between Dec 11, 2018 and Sep 14, 2022 — classified as 1 death, 5 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Premature End-of-Life Indicator” (2 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Premature End-of-Life Indicator2
- Failure to Interrogate1
Patient problems
- Unspecified Infection4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- Syncope/Fainting1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2022Adverse 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 15417982 ↗InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MalfunctionDec 29, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE WAS EXPLANTED AND REPLACED 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 13115263 ↗InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 12189212 ↗DeathDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT IS EXPIRED. THE FAMILY IS QUESTIONING FUNCTIONALITY OF THE DEVICE. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11015486 ↗InjurySep 16, 2020Failure to Interrogate; Failure to Interrogate
PATIENT HAD SYNCOPAL EPISODES AND WAS GETTING DEVICE CHECKED. DEVICE TECHNICIAN WAS UNABLE TO INTERROGATE THE DEVICE. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Syncope/Fainting
MAUDE report 10541178 ↗MalfunctionMar 26, 2020Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE WAS EXPLANTED AND REPLACED DUE TO EOL. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9886106 ↗InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. NEW SYSTEM WAS NOT IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 8151204 ↗
Other Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) devices
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- Quadra Allure MP™ PM3562St. Jude Medical, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)26 deaths1,180 reports
- Percepta™ Quad CRT-P MRI SureScan™ W4TR01Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)1 recall28 deaths897 reports
- VISIONIST™ X4 CRT-P U228Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)1 recall4 deaths819 reports
- Percepta™ Quad CRT-P MRI SureScan™ W4TR01Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)1 recall8 deaths703 reports
- INVIVE™ V173Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)1 death670 reports
- VALITUDE™ CRT-P U125Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)2 recalls2 deaths558 reports
- QUADRA ALLURE MP™ PM3262St. Jude Medical, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)27 deaths518 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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