Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Recall Z-0763-2019 · Posted 2019-01-31

Recalling FirmEdwards Lifesciences, LLC
Recall StatusTerminated
Product CodeDYG
Date Initiated2018-12-21
Date Terminated2023-11-02
Product Quantity875 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K160084Swan Ganz CathetersEdwards Lifesciences, LLC · 2016-05-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑