Covidien, LP: Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.

Agency Publication Date: April 9, 2021

Affected Products

Product: Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT

Lot Numbers: N0A1038UY N0E0016UY N0F0616UY N0K0934UY N0B0493UY N0F0254UY N0F0817UY N0M0334UY N0C0436UY N0F0518UY N0G0388UY N9K1095UY N0D0731UY N0F0615UY N0J0859UY N9L0797UY UDI: 10884521741843 20884521741840

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Product: Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV

Lot Numbers: N0A0191UY N0D0392UY N0F0406UY N0L0708UY N0B0657UY N0E0133UY N0G0907UY N9K0376UY N0C0349UY N0E0956UY N0J0746UY N9K1093UY N0C0492UY N0E1026UY N0K0248UY N9L0796UY N0C1008UY N0F0202UY N0K0803UY N9M0418UY N0D0283UY N0F0221UY N0L0307UY N9M0651UY UDI: 10884521741881 20884521741888

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Numbers

Product: Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT

Lot Numbers: N0A0274UY N0D0037UY N0G0491UY N0K1016UY N0A0897UY N0D0391UY N0G0736UY N0L0077UY N0B0640UY N0E0175UY N0J0510UY N0M0063UY N0B0937UY N0E0802UY N0J0680UY N0M0259UY N0C0144UY N0F1055UY N0J0999UY N9K1094UY N0C0486UY N0G0185UY N0K0584UY N9L0795UY N0C1115UY N0G0250UY N0K0805UY UDI: 10884521741874 20884521741871

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87475

Status: Resolved

Manufacturer: Covidien, LP

Manufactured In: United States

Units Affected: 3 products (5928 units WW: 4212 US 1716 OUS; 11391 units WW: 5982 US 5409 OUS; 15298 units WW: 9204 US; 6094 OUS)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT

Lot Numbers:

Numbers

Product: Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV

Lot Numbers:

Numbers

Product: Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT

Lot Numbers:

Numbers