ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutte
Summary
The FDA issued a Class II for ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON E by Ethicon Endo-Surgery Inc. Reason: There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient ti.
Details
Source
Device Recall
External ID
Z-0834-2024
Action Date
2024-02-07
Status
Ongoing
Category
device
Product Description
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
Lot/Code Info: UDI-DI 10705036014928 Lots 442C02 and 442C03
Quantity Affected: 22,616 (US), 4,476 (OUS)
Reason for Recall
There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-11
Company
Blue Ash, OH
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 221 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ethicon Endo-Surgery Inc has 6 FDA actions in our database, including 6 recalls.
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 (Ethicon Endo-Surgery Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ethicon Endo-Surgery Inc have FDA actions?
Ethicon Endo-Surgery Inc has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0834-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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