—#170201

Product

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 oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

FDA product code: DYG — Catheter, Flow Directed
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K160084
Affected lot / code info: Lot Numbers: 61321241, 61176369, 61176374, 61311580, 61176373, 61321254

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 1 Edwards Way, Irvine, California 92614-5688

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2018-12-21
Posted by FDA: 2019-01-31
Terminated: 2023-11-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170201. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.