Z-1700-2015Class II

Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery...

Name: Z-1700-2015 Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery...
Creator: Edwards Lifesciences, LLC
Published: 2015-05-05
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2015-05-05 / Terminated / root cause: manufacturing process

FDA source

Edwards Lifesciences, LLC began a recall of Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous... on 2015-05-05. FDA classified it as Class II and gives the reason as "The product failed to meet the internal established statistical test requirement for heparin activity". 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-1700-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-05
Posted: 2015-06-02
Terminated: 2016-10-17
Recalling firm: Edwards Lifesciences LLC
Product: Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with the Vigilance Monitor.
Product code: DYG Catheter, Flow Directed
Reason for recall: The product failed to meet the internal established statistical test requirement for heparin activity.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 05/05/2015 Edwards sent their consignees a letter including the following instructions: Once you have verified your inventory, please complete the attached acknowledgement form (even if you have no inventory) and fax it to Edwards Customer Service at 1-800-422-9329 within three days of receipt of this notification. This is to confirm that you have reviewed this notice and have taken appropriate action. Please call Edwards Customer Service at 1-800-424-3278 to arrange for return of any unused product from the identified lot and obtain information about replacement product. Please call for an RGA prior to returning any unused product and return unused product to the following address: Edwards Lifesciences Return Goods/RGA # XXXXXX 1212 Alton Pkwy., Irvine, CA 92606-4838
Quantity in commerce: 978
Distribution: Worldwide distribution US nationwide, Canada and Europe (IC, BE, IT, GB, FR, DK, CZ, DE, AT, ES, IE, NO, PL)
Product codes and lots: lot number 59860969.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1700-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1700-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-10	2015-06-02

Product code DYG

K940795Class IISwan-Ganz Cc0/svo2 Thermodilution CatheterBaxter Edwards / cleared 1994-05-24

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)