IceCure Cryoablation System ProSense Manual Updated for Mechanical Damage Safety
Icecure Medical Ltd is updating the user manual for IceCure Cryoablation System ProSense surgical devices to add safety guidelines for managing mechanical damage such as bent cryoprobes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall with a manual update addressing mechanical damage to a surgical instrument. While no injuries have been reported, the cryoablation system is a risk-of-harm device where mechanical failure during surgery could affect patient safety, meeting the criteria for High severity.
Plain-English summary
Icecure Medical Ltd is recalling the user manual for the IceCure Cryoablation System ProSense surgical devices (models FAS3000000 and FAS3000000-2) distributed nationwide. The updated manual includes new safety guidelines for managing mechanical damage—such as a bent cryoprobe—that may occur during use.
The cryoablation system is designed to destroy tissue using extreme cold during surgical procedures. The manual update is intended to help healthcare providers safely operate the device and address potential mechanical issues.
Healthcare facilities and surgical teams should review the updated user manual and follow the new safety guidelines for managing mechanical damage to the cryoprobe. Ensure all personnel involved in operating the device are familiar with the updated guidance.
The recalled product
- 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)
- Manufacturer
- Icecure Medical Ltd
- Hazard
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI: (1)FAS3000000
- UDI: 07290015487160 (2)FAS3000000-2
- UDI: 07290015487290 All User Manual Revisions up to Rev.D.
Distribution
Distributed nationwide across the United States.
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