# FDA recall Z-1533-2020

> **MEDTRONIC ATS MEDICAL, INC.** · Class II · device recall initiated 2020-02-11.

## Product

Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm

## Reason for recall

Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral.  The valve itself was correctly labeled as Mitral.

## Distribution

China

## Key facts

- **Recall number:** Z-1533-2020
- **Recalling firm:** MEDTRONIC ATS MEDICAL, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-11
- **Report date:** 2020-04-01
- **Termination date:** 2022-03-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1533-2020

## Citation

> AI Analytics. FDA recall Z-1533-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1533-2020. Source: US FDA. Licensed CC0.

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