Cerene Cryotherapy Device (Channel Medsystems) – gasket seal issue (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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, an
Brand
Channel Medsystems, Inc.
Lot Codes / Batch Numbers
Lot Code: Model No: FGS-7000 UDI-DI: 00850008595035 Lot Numbers: 108638953, 108645585, 108645586, 108645587, 108866674, 108866675, 109493291, 109493292 and 109895874
Products Sold
Lot Code: Model No: FGS-7000 UDI-DI: 00850008595035 Lot Numbers: 108638953, 108645585, 108645586, 108645587, 108866674, 108866675, 109493291, 109493292 and 109895874
Channel Medsystems, Inc. is recalling Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Cata due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
On 03/20/2025, the firm emailed customer an "URGENT MEDICAL DEVICE CORRECTION" Letter informing them that the evaporator gasket inside the handle of the device may not seal properly, 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. Customers are instructed to: 1. Check your internal inventory to determine if you have any affected devices. 2. Stop use of affected devices. 3. Vent the affected devices by following the attached instructions and then discard the devices according to your facility s procedures. 4. Complete and return the customer acknowledgement form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. Therefore, please complete the form even if you no longer have any of the affected devices in your physical inventory. 5. Circulate this letter to all other relevant parties, as needed. For questions, contact Channel Medsystems at safetynotice@cerene.com or at (510)338-9301 Monday thru Friday 8:00 AM to 5:00 PM Pacific Time
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026