FDA Device recall Z-2039-2020
Medtronic Confida Expandable Sheath, REF CES122230
- FDA Device
- Class I
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class I recall of Medtronic Confida Expandable Sheath, REF CES122230 by Medtronic Vascular Galway, citing increased risk of events associated with vascular complications (bleeding, hematoma, and dissection).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2039-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-05-12 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Vascular Galway |
| Distribution | AL, CA, MI, NY, TX, WI |
Product
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)
Identifiers
| code_info | UDI: 00763000233815, All Lot Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2039-2020%22
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