Edwards Lifesciences, LLC: 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)

Recall number

Z-1380-2023

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)

Status

Open, Classified

Initiated

2023-02-14

Posted

2023-04-12

Terminated

not on file

Reason

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

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 US.FCA@edwards.com 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 US.FCA@edwards.com. 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

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

Lot, serial or model codes

Primary DI Number: 00690103146998/ Lot: 64526520

510(k) numbers

not on file

PMA numbers

not on file

Product code

DYG

Firm FEI

2015691

Firm city

Irvine

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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