Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-70
Summary
The FDA issued a Class II for Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, E by Channel Medsystems, Inc.. 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 .
Details
Source
Device Recall
External ID
Z-1584-2025
Action Date
2025-04-23
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: Model No: FGS-7000 UDI-DI: 00850008595035 Lot Numbers: 108638953, 108645585, 108645586, 108645587, 108866674, 108866675, 109493291, 109493292 and 109895874
Quantity Affected: 281
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-20
Company
Berkeley, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 165 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Channel Medsystems, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Channel Medsystems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Channel Medsystems, Inc. have FDA actions?
Channel Medsystems, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1584-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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