Reported Jun 3, 2020 · Terminated

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

Medtronic Vascular Galway dba Medtronic Ireland

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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: Medtronic Vascular Galway DBA Medtronic Ireland · Parkmore Business Park West · Galway, N/A · N/A

Is this the product you have?

  • Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Lot codes and dates
  • UDI00763000233815, All Lot Numbers
Amount recalled
103 units

Where it was sold

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 10, 2022 · Data as of Sep 19, 4:51 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.