Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short It...

FDA Device Recall #Z-1384-2021 — Class II — March 4, 2021

Recall Summary

Recall Number Z-1384-2021
Classification Class II — Moderate risk
Date Initiated March 4, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Covidien, LP
Location North Haven, CT
Product Type Devices
Quantity 11391 units WW: 5982 US 5409 OUS

Product Description

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

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 Pattern

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.

Lot / Code Information

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

Other Recalls from Covidien, LP

Recall # Classification Product Date
Z-0485-2026 Class II Covidien Signia" Small Diameter Curved Tip Inte... Sep 25, 2025
Z-0486-2026 Class II Covidien Signia" Small Diameter Curved Tip Inte... Sep 25, 2025
Z-1891-2024 Class II Tri-Staple 2.0 Black Reinforced Intelligent Rel... Apr 15, 2024
Z-1469-2024 Class II Covidien Auto Suture" Blunt Tip Trocar, Product... Feb 28, 2024
Z-1470-2024 Class II Covidien Auto Suture" Blunt Tip Trocar, Product... Feb 28, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.