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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