# FDA recall Z-1590-2023

> **Abiomed, Inc.** · Class I · device recall initiated 2023-04-17.

## Product

Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)

## Reason for recall

The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.

## Distribution

US Nationwide. Japan, Saudi Arabia, Kuwait, Italy, Spain, Switzerland, Austria, France, Great Britain, Croatia, Serbia, Norway, Slovenia, Germany

## Key facts

- **Recall number:** Z-1590-2023
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-17
- **Report date:** 2023-05-24

- **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-1590-2023

## Citation

> AI Analytics. FDA recall Z-1590-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1590-2023. Source: US FDA. Licensed CC0.

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