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SWAN-GANZ CCOMBO V recallZ-1380-2023 · Edwards Lifesciences, LLC · initiated Feb 14, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Edwards Lifesciences, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Packaging process control

What the company is doing

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

Recall details

Recall number
Z-1380-2023
Status
Open, Classified
Initiated by the company
Feb 14, 2023
Posted by the FDA
Apr 12, 2023
Recalling firm
Edwards Lifesciences, LLC
Quantity
326 units
Product code
DYG
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 description

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)

Code information (models, lots, serial numbers)

Primary DI Number: 00690103146998/ Lot: 64526520

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 91868).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page