Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2014-01-24 | Z-1094-2014 | Class II | Terminated | NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,Distribution: Worldwide Distribution - USA Nationwide and the countries Canada, France, Germany, and Sweden | 93 units | clearance family |
Regulatory clearances
- PMAP01001330-day notice accepted (OK30) · 2025-12-17 · +19 earlier decisionsclearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-11-04 | OAI | Official action indicated | Hologic, Inc | 3 |
| 2025-11-04 | OAI | Official action indicated | Hologic, Inc | 3 |
| 2024-12-18 | WL | Warning Letter | Hologic, Inc | — |
| 2024-12-18 | WL | Warning Letter | Hologic, Inc | — |
| 2024-09-24 | OAI | Official action indicated | Hologic, Inc | 5 |
| 2024-09-24 | OAI | Official action indicated | Hologic, Inc | 5 |
| 2024-09-12 | VAI | Voluntary action indicated | Hologic Surgical Products Costa Rica, S.R.L. | 0 |
| 2024-08-13 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2024-08-13 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2022-12-14 | NAI | No action indicated | Bolder Surgical, LLC | 0 |
| 2022-10-14 | OAI | Official action indicated | Hologic, Inc. | 4 |
| 2022-10-14 | OAI | Official action indicated | Hologic, Inc. | 4 |
| 2022-08-03 | VAI | Voluntary action indicated | Health Beacons, Inc. | 1 |
| 2020-02-25 | NAI | No action indicated | Health Beacons, Inc. | 0 |
| 2018-12-10 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2018-12-10 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2018-02-27 | NAI | No action indicated | Gynesonics, Inc. | 0 |
| 2017-11-30 | NAI | No action indicated | Hologic, Inc | 0 |
| 2017-11-30 | NAI | No action indicated | Hologic, Inc | 0 |
| 2017-11-27 | VAI | Voluntary action indicated | Bolder Surgical, LLC | 6 |
| 2017-10-25 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2017-10-25 | NAI | No action indicated | Hologic, Inc. | 0 |
Similar devices
- Cerene Cryotherapy Device CHANNEL MEDSYSTEMS, INC.
- Exhaust Collection Bag CHANNEL MEDSYSTEMS, INC.
- Exhaust Collection Bag CHANNEL MEDSYSTEMS, INC.
- GYNECARE THERMACHOICE Ethicon Inc.
- GYNECARE THERMACHOICE Ethicon Inc.
- GYNECARE THERMACHOICE Ethicon Inc.
- GYNECARE THERMACHOICE Ethicon Inc.
- Genesys HTA Control Unit Minerva Surgical, Inc.
- Genesys HTA Control Unit - Refurbished Minerva Surgical, Inc.
- Genesys HTA ProCerva Minerva Surgical, Inc.
- Genesys HTA ProCerva BOSTON SCIENTIFIC CORPORATION
- Genesys HTA System BOSTON SCIENTIFIC CORPORATION
Select up to two to place side-by-side with this device.