Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cryogenic probe for cardiac ablation surgery Recalled by Atricure Inc Due to Affected product may have compromised sterility due to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Atricure Inc directly.
Affected Products
Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryo-necrosis) that blocks the electrical conduction pathway.
Quantity: 19,190 units
Why Was This Recalled?
Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Atricure Inc
Atricure Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report