Z-2039-2020 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- May 12, 2020
- Termination Date
- March 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 103 units
Product Description
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Reason for Recall
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
Distribution Pattern
US distribution in TX, WI, CA, NY, AL, and MI.
Code Information
UDI: 00763000233815, All Lot Numbers