FDA-Device2020-06-03Class I
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Medtronic Vascular Galway DBA Medtronic Ireland
Hazard
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
Sold states
US distribution in TX, WI, CA, NY, AL, and MI.
Affected count
103 units
Manufactured in
Parkmore Business Park West, N/A, Galway, N/A, Ireland
Products
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2039-2020Don't want to check this manually?
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