Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
- Recall Initiated
- May 12, 2020
- Posted
- May 27, 2020
- Terminated
- March 10, 2022
- Recall Number
- Z-2039-2020
- Quantity
- 103 units
Reason for Recall
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
Distribution
US distribution in TX, WI, CA, NY, AL, and MI.
Lot / Code Info
UDI: 00763000233815, All Lot Numbers
Root Cause
Process control
Action Taken
The firm initiated the recall on 05/12/2020 by letter. The notice instructed the consignee to quarantine the product and return it to Medtronic.
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