MEDTRONIC ATS MEDICAL Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7 recall — FDA Z-0495-2021
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Overview of recall records associated with MEDTRONIC ATS MEDICAL, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 5.
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled…
This page summarizes recall records in which the official source identifies MEDTRONIC ATS MEDICAL, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.