CLASS II Device recall · Reported 21 Apr 2021 · FDA Enforcement Report
Signia Small Diameter Curved Tip Intelligent Reload recalled by Covidien
Covidien is recalling Covidien Signia Small Diameter Curved Tip Intelligent Reload Vascular/Thin - Long, distributed nationwide in the US. The recall was initiated on 4 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1383-2021
- FDA event ID
- 87475
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Mar 2021
- FDA classified
- 9 Apr 2021
- Reported
- 21 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 4 Mar 2021 | Recall initiated by company | |
| 9 Apr 2021 | Classified by FDA | +36 days |
| 21 Apr 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
Where it was distributed
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.
Questions about this recall
Is Signia Small Diameter Curved Tip Intelligent Reload Vascular/Thin - Long recalled?
Yes. Covidien recalled Signia Small Diameter Curved Tip Intelligent Reload Vascular/Thin - Long on 4 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1383-2021.
Why was it recalled?
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.
Which lots are affected?
Lot Numbers: N0A1038UY N0E0016UY N0F0616UY N0K0934UY N0B0493UY N0F0254UY N0F0817UY N0M0334UY N0C0436UY N0F0518UY N0G0388UY N9K1095UY N0D0731UY N0F0615UY N0J0859UY N9L0797UY UDI: 10884521741843 20884521741840
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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