Medtronic Confida Expandable Sheath recall
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Why was Medtronic Confida Expandable Sheath recalled?
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00763000233815, All Lot Numbers
- Product
- Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
- Recalling firm
- Medtronic Vascular Galway DBA Medtronic Ireland
- Quantity
- 103 units
- Distribution
- US distribution in TX, WI, CA, NY, AL, and MI.
- Recall date
- June 3, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)