FDA Device recall Z-0765-2019
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnosti…
- FDA Device
- Class I
- terminated
- Published 2019-02-06
On 2019-02-06 the FDA classified a Class I recall of Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnosti… by Edwards Lifesciences, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0765-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-12-21 |
| Published | 2019-02-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Edwards Lifesciences |
| Distribution | n/a |
Product
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 balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
Reason
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.
Identifiers
| code_info | Lot Numbers: 61176367, 61176370 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0765-2019%22
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