Z-0764-2019Class I

Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P

Name: Z-0764-2019 Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P
Creator: Edwards Lifesciences, LLC
Published: 2018-12-21
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2018-12-21 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for... on 2018-12-21. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0764-2019
Classification: Class I
Status: Terminated
Initiated: 2018-12-21
Posted: 2019-01-31
Terminated: 2023-11-02
Recalling firm: Edwards Lifesciences LLC
Product: Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P 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.
Product code: DYG Catheter, Flow Directed
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 9 units
Distribution: Worldwide Distribution
Product codes and lots: Lot Number: 61176314

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0764-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0762-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-31
Z-0763-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-31
Z-0764-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-31
Z-0765-2019	Class I	Terminated	Voluntary: Firm initiated	2019-02-06	2019-01-31

Product code DYG

K160084Class IISwan Ganz CathetersEdwards Lifesciences, LLC / cleared 2016-05-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)