Galil Medical, Inc. recalls Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative…

Recall date

October 25, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0404-2020

FDA classification

Class II

Brand / firm

Galil Medical, Inc.

Sold / distributed

AK, AL, AR, AZ, CA, FL, GA, HI, KY, MA, MI, MN, NC, ND, NY, OH, PA, SC, TN, UT, VA, Puerto Rico OUS to include: Argentina, Canada, Taiwan, United Kingdom

Why it was recalled

Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively , by the use of Galil Medical I-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.