Reported Apr 21, 2021 · Terminated
Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
Covidien, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien, LP · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
- Covidien Signia Small Diameter Curved Tip Intelligent Reload 30
- mm Vascular/Thin 8 mm - Short Item CodeSIGSDS30CTVT
- Lot codes and dates
- Lot Numbers
N0A0274UYN0D0037UYN0G0491UYN0K1016UYN0A0897UYN0D0391UYN0G0736UYN0L0077UYN0B0640UYN0E0175UYN0J0510UYN0M0063UYN0B0937UYN0E0802UYN0J0680UYN0M0259UYN0C0144UYN0F1055UYN0J0999UYN9K1094UYN0C0486UYN0G0185UYN0K0584UYN9L0795UY
- N0C1115UY N0G0250UY N0K0805UY UDI10884521741874 20884521741871
- Lot Numbers
- Amount recalled
- 15298 units WW: 9204 US; 6094 OUS
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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