Signia Surgical Stapler Reload recalled for uncontrolled articulation
Covidien is recalling Signia Small Diameter Curved Tip Intelligent Reload surgical stapler reloads due to potential malfunction that could disrupt the staple line during use. The affected reloads may articulate uncontrollably due to unsecured components.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall for a surgical device with no reported illnesses or injuries to date. The uncontrolled articulation of the reload presents a risk of harm during surgical procedures, meeting the criteria for High severity where injury has not yet been reported.
Plain-English summary
Covidien, LP is recalling the Signia® Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT (Lot number N3L1909UY). This reload is a component used with the Endo GIA® Ultra Universal Stapler or Signia® Stapling System for surgical procedures.
Under certain firing conditions, affected reloads may articulate in an uncontrolled manner, potentially causing disruption to the staple line. This malfunction is caused by components within the reloads that are not fully secured.
The affected reloads were distributed worldwide, including throughout the United States and to France, Hong Kong, Israel, and Japan.
The recalled product
- Product
- Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
- Manufacturer
- Covidien, LP
- Affected units
- 30
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 (3)
- Model Number: SIGSDS30CTVT
- UDI/DI: 10884521741881
- Lot number: N3L1909UY
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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