# FDA recall Z-1385-2021

> **Covidien, LP** · Class II · device recall initiated 2021-03-04.

## Product

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

## Reason for recall

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.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Chile, China, Denmark, Finland,   France, Germany, Hong Kong, Ireland, Italy, Netherlands,   Norway, Poland, Portugal, Spain, Sweden, Switzerland,   United Kingdom.

## Key facts

- **Recall number:** Z-1385-2021
- **Recalling firm:** Covidien, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-04
- **Report date:** 2021-04-21
- **Termination date:** 2024-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Haven, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1385-2021

## Citation

> AI Analytics. FDA recall Z-1385-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1385-2021. Source: US FDA. Licensed CC0.

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