Device product
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Z-2039-2020
Product summary
- Event
- Event 85649
- Status
- Terminated
- Classification
- Class I
- Quantity
- 103 units
- Official record key
device-enforcement:Z-2039-2020
Official wording
Reason: Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
Code information: UDI: 00763000233815, All Lot Numbers
Distribution pattern: US distribution in TX, WI, CA, NY, AL, and MI.
Derived failure modes
-
Unknown
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)