Recall Z-0763-2019 ยท DYG Catheter, Flow Directed
Edwards Lifesciences, LLC
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
| Date | Jan 31, 2019 (initiated Dec 21, 2018) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Product Recall letter was sent via Fed-Ex to affected customers on 12/21/2018. A second communication was sent via Fed-Ex on 01/10/19. The letter identified the affected product, problem and actions to be taken. Customers were instructed to the return any unused units that are currently in their inventory. Once returned, replacement product will be shipped at no charge. Customers were asked to complete the attached acknowledgement form. For questions contact Technical Support at 1-800-822-8837 option 1. |
| Quantity | 875 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160084 | Swan Ganz Catheters Edwards Lifesciences, LLC, May 3, 2016 |