Amvia Edge HF-T QP 460162Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04035479174002), received between Dec 27, 2023 and Sep 1, 2026 — classified as 10 injuries.
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 Problem10
Patient problems
- Unspecified Infection9
- Chest Pain1
- Hematoma1
- Pericardial Effusion1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 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 50549697 ↗InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION (NOTICEABLE PUS IN POCKET). SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25112392 ↗InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
PER BIO-CONDUCT STUDY, PT PRESENTED TO THE ED FOR CHEST PAIN FOR 2 WEEKS THAT WORSENED, RADIATES ACROSS CHEST, UP INTO SHOULDERS AND STATES THAT IT HURTS TO BREATHE. ACTIVITY AND LYING FLAT MAKES IT WORSE. LAB-TROPONIN I <0.012(0-.120NG/ML). BTNP-461(<125PG/ML). CHEST XR-CARDIOMEGALY, NO ACUTE FINDINGS. CT CHEST-MODERATE PERICARDIAL EFFUSION, ADMITTING PT . TREATED WITH COLCHICINE AND TYLENOL, HEART TONES REMAINED EASILY AUDIBLE AND VS STABLE, REPEAT LIMITED ECHO SHOWED MEDIUM SIZE PERICARDIAL EFFUSION MAINLY POSTERIOR & LATERAL TO THE HEART WITH MAX 2.5CM THICKNESS, NO EVIDENCE OF TAMPONADE. PT OBSERVED FOR ANOTHER NIGHT AND DISCHARGED HOME WITH FOLLOW UP. DC01/18@1044AM.
Patient problems: Chest Pain; Pericardial Effusion
MAUDE report 24744206 ↗InjuryFeb 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: Unspecified Infection
MAUDE report 24462507 ↗InjuryFeb 17, 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 24365052 ↗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 22965859 ↗InjuryJul 23, 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 22579209 ↗InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION/HEMATOMA AROUND DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Hematoma; Unspecified Infection
MAUDE report 22534136 ↗InjuryJan 6, 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 21080833 ↗InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 18406936 ↗
Other Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) devices
- VALITUDE™ X4 CRT-P U128Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)2 recalls26 deaths2,073 reports
- 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 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