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NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number...

FDA Device Recall #Z-1094-2014 — Class II — January 24, 2014

Recall Summary

Recall Number Z-1094-2014
Classification Class II — Moderate risk
Date Initiated January 24, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Hologic, Inc
Location Marlborough, MA
Product Type Devices
Quantity 93 units

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.

Reason for Recall

NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,

Distribution Pattern

Worldwide Distribution - USA Nationwide and the countries Canada, France, Germany, and Sweden

Lot / Code Information

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

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Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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