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Brand Name: Cerene Cryotherapy Device recallZ-1889-2024 · Channel Medsystems, Inc. · initiated May 3, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Channel Medsystems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Codes).

FDA root cause category: Device Design

What the company is doing

On 05/03/2024, the firm sent an "URGENT FIELD SAFETY NOTICE" via email to customers informing them that Channel Medsystems is updating its troubleshooting instructions to further inform healthcare professionals on the safe use and troubleshooting of the Cerene Device. the IFU has been updated to clarify that error code 003 can occur at any time (not only before, but also during, or after cryoablation treatment) and to instruct the user to continue to follow the correctly displayed Cerene Device LCD message and corresponding IFU troubleshooting instructions specifically, Uterus Partially Treated, End procedure, Do NOT re-treat or Uterus Treated End procedure Do NOT re-treat as the Treatment Status & Next Steps matching the corresponding displayed Cerene Device LCD screen message/error code 003. Customer are instructed to: 1. Follow your facility s established procedures for handling updated labeling/documents, such as immediately providing a copy of this notice to relevant healthcare professionals and notifying them of the updated IFU (Troubleshooting) and its online availability. 2. No product is being recalled and you are not required to return devices or IFUs to Channel Medsystems. 3. Complete and return the acknowledgment form at the end of this urgent field safety notice within one month of receipt. Questions or assistance - contact the firm at 510-338-9301 or email [email protected] during Office Hours: Monday through Friday. 8:00 AM to 5:00 PM, Pacific Time.

Recall details

Recall number
Z-1889-2024
Status
Open, Classified
Initiated by the company
May 3, 2024
Posted by the FDA
May 23, 2024
Recalling firm
Channel Medsystems, Inc.
Quantity
1772
Product code
MNB
Distribution
Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin and the country of Netherlands.

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

Code information (models, lots, serial numbers)

Lot Code: Model No: FGS-7000 UDI-DI: 00850008595035 Lot Numbers: All non-expired lots manufactured through February 2024 101635693, 101635694, 101635695, 101635696, 102211255, 102211256, 102211257, 102211258, 102887363, 102887364, 103151029, 103151030, 103151031, 103151032, 103489753, 103489754, 103489755, 103489756, 103489757, 103925402, 104008714, 104008715, 104521903, 104521904, 104521905, 104521906, 104521907, 104808352, 104808353, 105418198, 105733204, 105733205

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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