MEDTRONIC ATS MEDICAL, INC. recalls Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a…

Recall date

October 12, 2020

Source

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

Recall number

Z-0493-2021

FDA classification

Class II

Brand / firm

MEDTRONIC ATS MEDICAL, INC.

Sold / distributed

Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.

Why it was recalled

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

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

What was recalled

Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: 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.