FDAMarch 4, 2021device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

covidien lpcovidiencovidien lp

UPCs

1088452174187420884521741871

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT — Recall Details · AllClear