Summary
The FDA issued a Class II for Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT by Covidien, LP. Reason: Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The iss.
Details
Source
Device Recall
External ID
Z-1457-2024
Action Date
2024-04-10
Status
Ongoing
Category
device
Product Description
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Lot/Code Info: Model Number: SIGSDS30CTVT; UDI/DI: 10884521741881; Lot number: N3L1909UY;
Quantity Affected: 30 Units
Reason for Recall
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
Distribution
Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-14
Company
North Haven, CT
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 200 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Covidien, LP has 89 FDA actions in our database, including 89 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 (Covidien, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Covidien, LP have FDA actions?
Covidien, LP has 89 FDA actions in our database, including 89 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1457-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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