# FDA recall Z-2964-2024

> **Abiomed, Inc.** · Class II · device recall initiated 2024-08-05.

## Product

Pump 381 Pump Set (US); Product Code: 1000080;

## Reason for recall

A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella Pumps during coronary interventions. Currently there is no Abiomed labeling (IFU etc.) content related to this potential interaction, so Abiomed will update the IFU to include information on this potential device interaction.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei Darussalam, Canada, Croatia, Czeck Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, U.A.E., United Kingdom.

## Key facts

- **Recall number:** Z-2964-2024
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-05
- **Report date:** 2024-09-11

- **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-2964-2024

## Citation

> AI Analytics. FDA recall Z-2964-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2964-2024. Source: US FDA. Licensed CC0.

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