# FDA recall Z-2281-2023

> **Abiomed, Inc.** · Class I · device recall initiated 2023-06-29.

## Product

Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323

## Reason for recall

A higher than expected rate of  thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis

## Distribution

US Nationwide distribution including in the states of AR, CA, FL, GA, LA, MA, MI, MO, NC, NJ, NY, OH, OR, SC, TX, and WI.

## Key facts

- **Recall number:** Z-2281-2023
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-29
- **Report date:** 2023-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Danvers, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2281-2023

## Citation

> AI Analytics. FDA recall Z-2281-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2281-2023. Source: US FDA. Licensed CC0.

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