# FDA recall Z-1532-2021

> **Medtronic Inc.** · Class II · device recall initiated 2021-03-16.

## Product

Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

## Reason for recall

Incorrect size printed on the device; packaging is labeled correctly.

## Distribution

US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.

## Key facts

- **Recall number:** Z-1532-2021
- **Recalling firm:** Medtronic Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-16
- **Report date:** 2021-05-12
- **Termination date:** 2024-04-15

- **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-1532-2021

## Citation

> AI Analytics. FDA recall Z-1532-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1532-2021. Source: US FDA. Licensed CC0.

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