# FDA recall Z-1881-2019

> **Medtronic Inc** · Class II · device recall initiated 2019-05-21.

## Product

Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

## Reason for recall

Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.

## Key facts

- **Recall number:** Z-1881-2019
- **Recalling firm:** Medtronic Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-21
- **Report date:** 2019-07-03
- **Termination date:** 2020-10-07

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1881-2019

## Citation

> AI Analytics. FDA recall Z-1881-2019. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-1881-2019. Source: US FDA. Licensed CC0.

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