Covidien Signia Surgical Stapler Reloads Recalled Due to Articulation Defect
Covidien is recalling certain Signia surgical stapler reloads due to unsecured components that can cause uncontrolled articulation during use, potentially disrupting the staple line. The recall affects 3,023 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a structural component defect that can cause malfunction during surgery. While no illnesses or injuries have been reported, the defect poses a risk of surgical complication during critical procedures where proper staple placement is essential.
Plain-English summary
Covidien, LP is recalling approximately 3,023 units of its Signia Small Diameter Curved Tip Intelligent Reload (Model SIGSDS30CTVT) due to a defect in certain components.
Under specific firing conditions, the reloads can articulate in an uncontrolled manner. This occurs because components in the affected reloads are not fully secured, causing the instrument to move unpredictably. When this happens, the staple line—the row of staples being placed during surgery—can be disrupted, potentially compromising the surgical outcome.
The defect can affect the device when used with either the Endo GIA Ultra Universal Stapler or the Signia Stapling System. The affected lot numbers are: N3L1909UY, N3L1868UY, N3L2008UY, N3L2221UY, N3M1541UY, N3M1603UY, and N3M1639UY.
The reloads have been distributed worldwide, including throughout the United States and to France, Hong Kong, Israel, and Japan. Healthcare providers and facilities using these lot numbers should stop using affected units immediately and contact Covidien for guidance on replacement options.
The recalled product
- Product
- Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
- Manufacturer
- Covidien, LP
- Hazard
- uncontrolled-articulation
- component-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Model Number: SIGSDS30CTVT
- UDI/DI: 10884521741888
- Lot numbers: N3L1909UY
- N3L1868UY
- N3L2008UY
- N3L2221UY
- N3M1541UY
- N3M1603UY
- N3M1639UY
Distribution
Distributed nationwide across the United States.
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