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FDAMay 12, 2020device

Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)

What to do

FDA enforcement status: Terminated

Brands named

medtronic vascular galway dba medtronic irelandmedtronicmedtronic vascular

UPCs

00763000233815

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries. — Recall Details · AllClear