WiSE CRT System 5100Recalls & reported problems
EBR Systems, Inc. · Programmer · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00859244007296), received between Jul 18, 2025 and Jul 18, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Erratic or Intermittent Display” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Erratic or Intermittent Display1
Patient problems
- Unspecified Heart Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IN EACH INSTANCE, THE SCREEN ABRUPTLY TURNED BLACK WITHOUT ANY IDENTIFIABLE TRIGGERING ACTION. FOR TWO OF THE EPISODES, THE EBR SALES REPRESENTATIVE WAS ABLE TO RESTORE FUNCTIONALITY BY PERFORMING A SHORT PRESS OF THE POWER BUTTON AFTER WAITING 20-30 SECONDS, WITH THE DEVICE RETURNING TO THE SAME SCREEN AND ALLOWING WORK TO CONTINUE UNINTERRUPTED. IN THE THIRD EPISODE, A LONG PRESS OF THE POWER BUTTON CAUSED THE DEVICE TO REBOOT, REQUIRING THE REPRESENTATIVE TO RECONNECT TO THE WISE SYSTEM AND NAVIGATE BACK TO THE PREVIOUS SCREEN.
Patient problems: Unspecified Heart Problem
MAUDE report 22549409 ↗
Other Leadless Cardiac Resynchronization Therapy (Crt) devices
- WiSE CRT System 1000EBR Systems, Inc. · Leadless Cardiac Resynchronization Therapy (Crt)1 death31 reports
- WiSE CRT System 4100EBR Systems, Inc. · Leadless Cardiac Resynchronization Therapy (Crt)2 deaths18 reports
- WiSE CRT System 3100EBR Systems, Inc. · Leadless Cardiac Resynchronization Therapy (Crt)9 reports
- WiSE CRT System 2000EBR Systems, Inc. · Leadless Cardiac Resynchronization Therapy (Crt)1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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