Z-2198-2012Class II

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require...

Name: Z-2198-2012 Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require...
Creator: Edwards Lifesciences, LLC
Published: 2012-05-11
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2012-05-11 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring on 2012-05-11. FDA classified it as Class II and gives the reason as "The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter". 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-2198-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-11
Posted: 2012-08-12
Terminated: 2014-06-17
Recalling firm: Edwards Lifesciences LLC
Product: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
Product code: DYG Catheter, Flow Directed
Reason for recall: The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Edwards Lifesciences sent a "PRODUCT RECALL" letter dated May 8, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Confirmation Form was attached for customers to complete and return via fax to 1-800-422-9329. Contact Customer Service at 1-800-424-3278 for questions regarding this notice.
Quantity in commerce: 32,145 units for all products in Recall Event
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).
Product codes and lots: 59267057

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2198-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2188-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-12
Z-2189-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-12
Z-2190-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-12
Z-2191-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-12
Z-2192-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-12
Z-2193-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-12
Z-2194-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-12
Z-2195-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-12
Z-2196-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-12
Z-2197-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-12
Z-2198-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-12

Product code DYG

K810352Class IISwan-Ganz Flow-Directed ThermodilutionAmerican Edwards Laboratories / cleared 1981-03-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)