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Medtronic Vascular Galway DBA Medtronic Ireland recalls Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the fem
Recalled June 3, 2020 · FDA recall Z-2039-2020 · Medtronic Vascular Galway
Hazard
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection) · FDA Class I
Units
103 units
Sold at
US distribution in TX, WI, CA, NY, AL, and MI.
Description
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
Product
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Manufacturer(s)
Medtronic Vascular Galway DBA Medtronic Ireland
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →