Z-1584-2025Class II

Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog...

Name: Z-1584-2025 Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog...
Creator: Channel Medsystems, Inc.
Published: 2025-03-20
License: https://open.fda.gov/license/

Channel Medsystems / initiated 2025-03-20 / Open, Classified

FDA source

Channel Medsystems, Inc. began a recall of Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene... on 2025-03-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1584-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-20
Posted: 2025-04-16
Recalling firm: Channel Medsystems
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
Product code: MNB Device, Thermal Ablation, Endometrial
Reason for recall: 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
FDA root cause: Under Investigation by firm
Action: 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 [email protected] or at (510)338-9301 Monday thru Friday 8:00 AM to 5:00 PM Pacific Time
Quantity in commerce: 281
Distribution: U.S Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, KY, LA, MD, MO, NC, NY, OH, PA, PR, RI, TN, TX.
Product codes and lots: Lot Code: Model No: FGS-7000 UDI-DI: 00850008595035 Lot Numbers: 108638953, 108645585, 108645586, 108645587, 108866674, 108866675, 109493291, 109493292 and 109895874

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1584-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1584-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-16

Product code MNB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)