Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cardioblate CryoFlex Recalled by MEDTRONIC ATS MEDICAL, INC. Due to There is a potential defect in the seals...
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 MEDTRONIC ATS MEDICAL, INC. directly.
Affected Products
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
Quantity: 3 units
Why Was This Recalled?
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About MEDTRONIC ATS MEDICAL, INC.
MEDTRONIC ATS MEDICAL, INC. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report