WiSE CRT System 2000Recalls & reported problems
EBR Systems, Inc. · Delivery Sheath · Class 3 · Implant
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 00859244007067), received between Feb 27, 2026 and Feb 27, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Eject” (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
- Failure to Eject1
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.
MalfunctionFeb 27, 2026Failure to Eject
IT WAS REPORTED THAT AT THE 1-MONTH FOLLOW-UP ON (B)(6) 2026, THE WISE CRT SYSTEM DEMONSTRATED NORMAL DEVICE PERFORMANCE. BATTERY VOLTAGE WAS 2.94 V WITH 96% REMAINING CAPACITY AND A NORMAL BATTERY CURVE. THE SYSTEM MAINTAINED STABLE RV PACING DETECTION (EDGES ~1.007) WITH A MEAN ACOUSTIC DISTANCE OF 7.8 CM AND BIV PACING OF 97%. PROGRAMMING WAS OPTIMIZED BY CHANGING THE TARGETING MODE TO REDUCED GLOBAL SEARCH AND DISABLING THE VERTICAL AND FRONT-BACK SENSORS. NO DEVICE MALFUNCTIONS OR PERFORMANCE CONCERNS WERE IDENTIFIED.
Patient problems: Unspecified Heart Problem
MAUDE report 24476946 ↗
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 5100EBR 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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