FDA Recall
Terminated
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Recall: Z-2039-2020
·
Initiated May 12, 2020
Recall
- Recall Number
- Z-2039-2020
- Event Number
- 85649
- Firm
- Medtronic Vascular Galway DBA Medtronic Ireland Parkmore Business Park West Galway Ireland
- FEI Number
- 3002806434
- Product Code
- DYB
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- May 12, 2020
- Posted
- May 27, 2020
- Terminated
- March 10, 2022
Description
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Reason
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
Action
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.
Distribution
US distribution in TX, WI, CA, NY, AL, and MI.
Quantity
103 units