Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Medtronic Confida Expandable Sheath Recalled by Medtronic Vascular Galway DBA Medtronic Ireland Due to Increased risk of events associated with vascular complications...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Vascular Galway DBA Medtronic Ireland directly.
Affected Products
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Quantity: 103 units
Why Was This Recalled?
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
Where Was This Sold?
This product was distributed to 6 states: AL, CA, MI, NY, TX, WI
About Medtronic Vascular Galway DBA Medtronic Ireland
Medtronic Vascular Galway DBA Medtronic Ireland has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report