FDA Device recall Z-1584-2025
Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Descriptio…
- FDA Device
- Class II
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class II recall of Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Descriptio… by Channel Medsystems, citing due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1584-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-20 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Channel Medsystems |
| Distribution | US |
Product
Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to reduce future menstrual bleeding. The device is intended for use by healthcare professionals who have received appropriate training and are familiar with the principles, clinical applications, complications, side effects, and hazards commonly associated with endometrial ablation. The Cerene Device is single use, disposable, and provided sterile. The average procedure time is 7 minutes, with 2.5 minutes of active cryoablation. Ablation is achieved throughout the uterine cavity through the use of cryothermic energy. The cryothermic energy is provided by a liquid-to-gas phase change of N2O. During the 2.5-minute treatment cycle, liquid N2O (originating from a small Cylinder located in the device handle) flows through a delivery line and into an inflow line with multiple jets. This liquid N2O is infused into an ultra-thin polyurethane Liner, where it converts into gas. The gaseous N2O is exhausted through the Exhaust Hose exiting the bottom of the handle. Component: N/A
Reason
Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device
Identifiers
| code_info | Lot Code: Model No: FGS-7000 UDI-DI: 00850008595035 Lot Numbers: 108638953, 108645585, 108645586, 108645587, 108866674,…Lot Code: Model No: FGS-7000 UDI-DI: 00850008595035 Lot Numbers: 108638953, 108645585, 108645586, 108645587, 108866674, 108866675, 109493291, 109493292 and 109895874 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1584-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.