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MEDTRONIC ATS MEDICAL Recalls
5 recalls on record · April 1, 2020 to December 2, 2020 · Medical Devices
December 2, 2020Medical DevicesFDA
MEDTRONIC ATS MEDICAL, INC. recalls Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, dis
Hazard: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
December 2, 2020Medical DevicesFDA
MEDTRONIC ATS MEDICAL, INC. recalls Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, dispo
Hazard: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
December 2, 2020Medical DevicesFDA
MEDTRONIC ATS MEDICAL, INC. recalls Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disp
Hazard: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
December 2, 2020Medical DevicesFDA
MEDTRONIC ATS MEDICAL, INC. recalls Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a s
Hazard: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
April 1, 2020Medical DevicesFDA
MEDTRONIC ATS MEDICAL, INC. recalls Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Hazard: 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 as Mitral.