Mara Console GEN-16-050 (UDI 00888937026870)Recalls & reported problems
Coopersurgical, Inc. · Mara Console- Endometrial Ablation · Class 3
Data updated Oct 18, 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 00888937026870), received between Jan 21, 2025 and Jan 21, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Protective Measures Problem” (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. 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
- Protective Measures Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2025Protective Measures Problem; Protective Measures Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21199677 ↗
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- NovaSure NS2013USHologic, Inc. · DEVICE, THERMAL ABLATION, ENDOMETRIAL112 reports
- Minerva Single Sterile Disposable Handpiece MIN9770Minerva Surgical, Inc. · Device, Thermal Ablation, Endometrial98 reports
- NovaSure V5Hologic, Inc. · Device, thermal ablation, endometrial2 deaths92 reports
- Genesys HTA ProCerva M006580210Boston Scientific Corporation · DEVICE, THERMAL ABLATION, ENDOMETRIAL91 reports
- NovaSure NS2000USHologic, Inc. · DEVICE, THERMAL ABLATION, ENDOMETRIAL77 reports
- NovaSure V5Hologic, Inc. · Device, thermal ablation, endometrial60 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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