Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
Reported: June 3, 2020 Initiated: May 12, 2020 #Z-2039-2020
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)
Details
- Recalling Firm
- Medtronic Vascular Galway DBA Medtronic Ireland
- Units Affected
- 103 units
- Distribution
- US distribution in TX, WI, CA, NY, AL, and MI.
- Location
- Galway, N/A
Frequently Asked Questions
What product was recalled? ▼
Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.. Recalled by Medtronic Vascular Galway DBA Medtronic Ireland. Units affected: 103 units.
Why was this product recalled? ▼
Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 3, 2020. Severity: Critical. Recall number: Z-2039-2020.
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