Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F
Summary
The FDA issued a Class II for Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodi by Edwards Lifesciences, LLC. 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, th.
Details
Source
Device Recall
External ID
Z-1380-2023
Action Date
2023-04-19
Status
Ongoing
Category
device
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)
Lot/Code Info: Primary DI Number: 00690103146998/ Lot: 64526520
Quantity Affected: 326 units
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-14
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 135 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Edwards Lifesciences, LLC has 59 FDA actions in our database, including 35 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Edwards Lifesciences, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Edwards Lifesciences, LLC have FDA actions?
Edwards Lifesciences, LLC has 59 FDA actions in our database, including 35 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1380-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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