Icecure Medical Ltd 7, Ha-Eshel Caesarea Israel IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)
Brand
Icecure Medical Ltd 7, Ha-Eshel Caesarea Israel
Lot Codes / Batch Numbers
UDI: (1)FAS3000000, UDI: 07290015487160 (2)FAS3000000-2, UDI: 07290015487290 All User Manual Revisions up to Rev.D.
Products Sold
UDI: (1)FAS3000000, UDI: 07290015487160 (2)FAS3000000-2, UDI: 07290015487290 All User Manual Revisions up to Rev.D.
Icecure Medical Ltd 7, Ha-Eshel Caesarea Israel is recalling IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical p due to Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe). Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)
Recommended Action
Per FDA guidance
IceCure notified users on Sep.16th,2019 via email. IceCure Medical has updated the User Manual DSR3200000 Rev. E to include safety guidelines in case of any mechanical damage (e.g. bent cryoprobe) the cryoprobe. Letter states reason for recall, health risk and action to take: The user manual can be found at IceCure Medical website or If you would like to acquire our paper form user manual book, please contact us directly and one will be sent to you within 7 working days. We can be reached at +1-646-844-3066 or via email at icecuresupport@icecure-medical.com
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