Medtronic Confida Expandable Sheath — Class I medical device recall Z-2039-2020
Terminated recall by Medtronic Vascular Galway DBA Medtronic Ireland, reported 2020-06-03, distributed in AL, CA, MI, NY, TX, WI. Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)
| Recall number | Z-2039-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular Galway DBA Medtronic Ireland, Galway, N/A, Ireland |
| Recall initiated | 2020-05-12 |
| Classified | 2020-05-27 |
| Reported by FDA | 2020-06-03 |
| Terminated | 2022-03-10 |
| Distributed | AL, CA, MI, NY, TX, WI |
| Quantity | 103 units |
| UPC / GTIN / UDI-DI | 00763000233815 |
| Model numbers | CES122230 |
Product
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)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2039-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.