Agency classClass IIOur severity:Severe FDA (Devices)·Z-1385-2021·Announced 2021-04-21

Recall of Covidien Signia Stapler Reloads Due to Safety Interlock Failure

FDA is recalling specific lots of Covidien Signia stapler reloads because a safety interlock may fail, allowing empty reloads to be fired.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a device malfunction that can lead to significant patient injury, including bleeding, tissue trauma, and the need for open surgery.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling specific lots of the Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short (Item Code: SIGSDS30CTVT). The recall involves 15,298 units distributed worldwide, including nationwide distribution in the United States and in Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and the United Kingdom.

The recall is due to a potential failure of the device's safety interlock. This interlock is designed to prevent an empty single-use reload from being fired a second time. If the interlock fails and the empty reload is fired, the stapler may cut tissue without deploying staples. This malfunction can result in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open surgical procedure.

Healthcare providers and facilities should check their inventory for the specific lot numbers and UDI codes listed in the official recall notice. If the affected devices are in use, they should be removed from service and returned to the manufacturer or disposed of according to the recall instructions provided by Covidien, LP.

The recalled product

Product: Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
Manufacturer: Covidien, LP
Category: Medical Device — Surgical Staplers
Hazard: device-malfunction
tissue-trauma
bleeding

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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.

See all 3 products in this recall →

Same manufacturer · Covidien, LP

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