Summary
The FDA issued a Class II for Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 by Edwards Lifesciences, LLC. Reason: Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds)..
Details
Source
Device Recall
External ID
Z-0238-2024
Action Date
2023-11-15
Status
Ongoing
Category
device
Product Description
Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
Lot/Code Info: UDI-DI: 00690103043532, Lot: 64936927
Quantity Affected: 185
Reason for Recall
Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).
Distribution
OUS: Singapore, Taiwan, Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-07
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 171 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-0238-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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