MEDTRONIC ATS MEDICAL

5 recalls •

🏥 Medical Devices

• Categories: Diagnostic Equipment, Infusion Pumps

Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 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.

Class I - Dangerous

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

Oct 12, 2020 Diagnostic Equipment Nationwide View Details →

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.

Class I - Dangerous

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

Oct 12, 2020 Diagnostic Equipment Nationwide View Details →

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.

Class I - Dangerous

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

Oct 12, 2020 Diagnostic Equipment Nationwide View Details →

Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 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.

Class I - Dangerous

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

Oct 12, 2020 Diagnostic Equipment Nationwide View Details →

Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm

Class I - Dangerous

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.

Feb 11, 2020 Infusion Pumps View Details →