NovaSure Impedance Controlled Endometrial Ablation System… recallZ-1094-2014 · Hologic, Inc · initiated Jan 24, 2014
Class II Terminated All recalls posted in February 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,
FDA root cause category: Component design/selection
What the company is doing
Hologic sent an Important Medical Device Information letter to all affected consignees on January 24, 2014 via certified letter. The letter contains instructions for scheduling the return and replacement of the affected unit, provides contact information, and includes a postage-paid return card for the consignee to complete and return to Hologic.
Recall details
- Recall number
- Z-1094-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 24, 2014
- Posted by the FDA
- Feb 26, 2014
- Recalling firm
- Hologic, Inc
- Quantity
- 93 units
- Product code
- MNB
- FDA submissions
- P010013
- Distribution
- Worldwide Distribution - USA Nationwide and the countries Canada, France, Germany, and Sweden
Product description
NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Serial Numbers: 33907H13D0 33911H13D0 33913H13D0 33915H13D0 33917H13D0 33919H13D0 33947I13D0 34014J13D0 34010J13D0 34009J13D0 34011J13D0 33868H13D0 33869H13D0 33870H13D0 33871H13D0 33872H13D0 33873H13D0 33874H13D0 33875H13D0 33876H13D0 33877H13D0 33878H13D0 33879H13D0 33880H13D0 33881H13D0 33882H13D0 33883H13D0 33884H13D0 33885H13D0 33886H13D0 33888H13D0 33889H13D0 33890H13D0 33891H13D0 33892H13D0 33893H13D0 33894H13D0 33895H13D0 33896H13D0 33897H13D0 33898H13D0 33900H13D0 33901H13D0 33902H13D0 33903H13D0 33904H13D0 33948I13D0 33951I13D0 33952I13D0 33953I13D0 33954I13D0 33955I13D0 33956I13D0 33957I13D0 33958I13D0 33959I13D0 33960I13D0 33961I13D0 33962I13D0 33963I13D0 33964I13D0 33965I13D0 33966I13D0 33967I13D0 33968I13D0 33969I13D0 33978J13D0 33979J13D0 33980J13D0 33981J13D0 33982J13D0 33983J13D0 33984J13D0 33990J13D0 33991J13D0 33995J13D0 33997J13D0 33998J13D0 34000J13D0 34001J13D0 34003J13D0 34017K13D0 34021K13D0 34023K13D0 34026K13D0 34027K13D0 34028K13D0 34029K13D0 34031K13D0 34032K13D0 34033K13D0 34035K13D0 34039K13D0
Other devices under the same FDA submission
7 devices cleared under P010013 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NovaSure SureSound 2013Hologic, Inc. · DEVICE, THERMAL ABLATION, ENDOMETRIAL151 reports
- NovaSure NS2013USHologic, Inc. · DEVICE, THERMAL ABLATION, ENDOMETRIAL112 reports
- NovaSure V5Hologic, Inc. · Device, thermal ablation, endometrial2 deaths92 reports
- NovaSure NS2000USHologic, Inc. · DEVICE, THERMAL ABLATION, ENDOMETRIAL77 reports
- NovaSure V5Hologic, Inc. · Device, thermal ablation, endometrial60 reports
- NovaSure SureSound 2007Hologic, Inc. · DEVICE, THERMAL ABLATION, ENDOMETRIAL31 reports
- NovaSure NovaSure ControllerHologic, Inc. · DEVICE, THERMAL ABLATION, ENDOMETRIAL3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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