Edwards Lifesciences, LLC - SwanGanz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter - Class 2 Recall
Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm) (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2023 Category: Medical Devices Source Type: alerts

Edwards Lifesciences, LLC - SwanGanz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter - Class 2 Recall
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm) (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2023 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 30 cm, PMAP, Expanded Kit - Class 2 Recall
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - TriOx ScvO2 Central Venous Oximetry Catheter, Heparin Coated, Expanded Kit - Class 2 Recall
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - Central Venous Catheter, Heparin Coated, 2 Lumen, 16/16 G, 20 cm, PMAP, Expanded Kit - Class 2 Recall
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41406-23 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 20 cm, MAP, Basic Kit - Class 2 Recall
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 20 cm, PMAP, Expanded Kit - Class 2 Recall
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-23. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 20 cm, LAV, Expanded Kit - Class 2 Recall
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-25. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 14 cm, LAV, Expanded Kit - Class 2 Recall
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41411-25 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Edwards Lifesciences, LLC - Swan Ganz Thermodilution Catheter - Class 1 Recall
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport b...
Source: Medical Device Recalls - February 1, 2019 Category: Medical Devices Source Type: alerts

Edwards Lifesciences, LLC - Swan Ganz Thermodilution Catheter - Class 1 Recall
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport ba...
Source: Medical Device Recalls - February 1, 2019 Category: Medical Devices Source Type: alerts

Edwards Lifesciences, LLC - Swan Ganz Thermodilution Catheter - Class 1 Recall
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport ...
Source: Medical Device Recalls - February 1, 2019 Category: Medical Devices Source Type: alerts

Edwards Lifesciences, LLC - Swan Ganz Thermodilution Catheter - Class 1 Recall
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of ...
Source: Medical Device Recalls - February 1, 2019 Category: Medical Devices Source Type: alerts

Edwards Lifesciences, LLC - HemoSphere Advanced Monitor, HemoSphere SwanGanz Module, and HemoSphere Oximetry Cable - Class 2 Recall
Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSGM10) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It ...
Source: Medical Device Recalls - January 17, 2018 Category: Medical Devices Source Type: alerts

Edwards Lifesciences, LLC - SwanGanz CCO/Sv02/CEDV/VIP Thermodilution Catheters - Class 2 Recall
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 3, 2015 Category: Medical Equipment Source Type: alerts