# FDA recall Z-2115-2023

> **Abiomed, Inc.** · Class I · device recall initiated 2023-06-14.

## Product

Impella CP intravascular micro axial blood pump, Product Number 0048-0032

## Reason for recall

There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.

## Distribution

Worldwide distribution - US Nationwide.

## Key facts

- **Recall number:** Z-2115-2023
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-14
- **Report date:** 2023-07-26

- **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-2115-2023

## Citation

> AI Analytics. FDA recall Z-2115-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2115-2023. Source: US FDA. Licensed CC0.

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