Z-0762-2019 Class I Terminated
FDA device recall Z-0762-2019 was initiated by Edwards Lifesciences, LLC on Dec 21, 2018 and is designated Class I. Reason for recall: These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms. The recall status is terminated (terminated Nov 2, 2023). Affected quantity: 277 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 6, 2019
- Initiation Date
- Dec 21, 2018
- Termination Date
- Nov 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 277 units
Product Description
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 balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
Reason for Recall
These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.
Distribution Pattern
Worldwide Distribution
Code Information
Lot Numbers: 61321177, 61227528
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0762-2019
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026