# FDA recall Z-0345-2020

> **Abiomed, Inc.** · Class II · device recall initiated 2019-09-04.

## Product

lmpella CP with Smart Assist,  Model Number: 0048-0003.  Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI

## Reason for recall

This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at P9 for all selected P-levels, rather than a 10 second ramp up period. The pump may have migrated out of position and possibly caused injury. The positioning and suction alarms were also disabled.

## Distribution

The product was distributed to GA

## Key facts

- **Recall number:** Z-0345-2020
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-04
- **Report date:** 2019-11-13
- **Termination date:** 2020-01-21

- **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-0345-2020

## Citation

> AI Analytics. FDA recall Z-0345-2020. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-0345-2020. Source: US FDA. Licensed CC0.

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