# FDA recall Z-2039-2020

> **Medtronic Vascular Galway DBA Medtronic Ireland** · Class I · device recall initiated 2020-05-12.

## 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)

## Distribution

US distribution in TX, WI, CA, NY, AL, and MI.

## Key facts

- **Recall number:** Z-2039-2020
- **Recalling firm:** Medtronic Vascular Galway DBA Medtronic Ireland
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-12
- **Report date:** 2020-06-03
- **Termination date:** 2022-03-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Galway, N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2039-2020

## Citation

> AI Analytics. FDA recall Z-2039-2020. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2039-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*