Z-1380-2023Class II

Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior...

Name: Z-1380-2023 Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior...
Creator: Edwards Lifesciences, LLC
Published: 2023-02-14
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2023-02-14 / Open, Classified / root cause: packaging

FDA source

Edwards Lifesciences, LLC began a recall of Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm... on 2023-02-14. FDA classified it as Class II and gives the reason as "There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1380-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-14
Posted: 2023-04-12
Recalling firm: Edwards Lifesciences LLC
Product: Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
Product code: DYG Catheter, Flow Directed
Reason for recall: There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On March 10, 2023, Edwards issued a "Urgent Medical Device Correction" notification to affected consignees. In addition to informing consignees about the correction, Edwards ask consignees to take the following actions: Actions to be taken by customer 1. Review the customer letter for advice on action to be taken. 2. Please follow the instructions included in the enclosed acknowledgement form to complete the acknowledgement process. 3. Distribute this notice within your organization or to any organization where the potentially impacted product has been transferred. 4. Please post a copy of this notice near and/or with affected devices. 5. Verify your inventory on the attached acknowledgement form. 6. Contact Edwards Customer Service at 1-888-352-0904 for a Return Goods Authorization (RGA) if you would like an exchange of your device or to request a biokit if returning used devices. Actions to be taken by distributors: 1. Please review this letter and complete the acknowledgement form. Return the acknowledgement form to [email protected] within 15 days of receipt of this notification. Please forward this customer communication to any of your customers who have purchased the impacted Edwards product. If you still have product within your control, please do not distribute impacted product to any customers. You can call Edwards Customer Service for instructions for handling product still within your control. 2. Alternatively, you can provide Edwards with a list of your customers who have purchased the impacted product from you and Edwards will communicate directly with your customers to facilitate the correction and acknowledgement process. Please forward your customer list to [email protected]. If you have any questions, please contact Edwards Customer Service at: 1-888-352-0904. Adverse Event Reporting in the US: 1. Please contact the FDA s MedWatch Adverse Event reporting program either online, by regular mail, or by fax: Complete and submit the report Onl
Quantity in commerce: 326 units
Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY OUS: None
Product codes and lots: Primary DI Number: 00690103146998/ Lot: 64526520

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1380-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1379-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12
Z-1380-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12

Product code DYG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)