NovaSure NovaSure ControllerRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15420045500860), received between Jun 8, 2021 and Jun 8, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P010013); they may or may not involve this specific model.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2021Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE THE DEVICE STARTED GETTING HOT FOR A FEW SECONDS PRIOR TO THE ABLATION. NO INJURY TO THE PATIENT OR USER WAS REPORTED. ANOTHER NOVASURE WAS USED AND AFTER THE PROCEDURE A HOLE IN THE ARRAY WAS OBSERVED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962625 ↗
• MalfunctionJun 8, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE THE DEVICE STARTED GETTING HOT FOR A FEW SECONDS PRIOR TO THE ABLATION. NO INJURY TO THE PATIENT OR USER WAS REPORTED. ANOTHER NOVASURE WAS USED AND AFTER THE PROCEDURE A HOLE IN THE ARRAY WAS OBSERVED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962619 ↗
• MalfunctionJun 8, 2021Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE THE DEVICE STARTED GETTING HOT FOR A FEW SECONDS PRIOR TO THE ABLATION. NO INJURY TO THE PATIENT OR USER WAS REPORTED. ANOTHER NOVASURE WAS USED AND AFTER THE PROCEDURE A HOLE IN THE ARRAY WAS OBSERVED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962595 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010013. One submission often covers many models, so check the product and lot details in each record.

• Z-1094-2014 · Jan 24, 2014 · Terminated
  NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Contro