# FDA recall Z-0636-2024

> **Abiomed, Inc.** · Class II · device recall initiated 2023-12-06.

## Product

Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.

## Reason for recall

The following features have been disabled from the web-based portal because the FDA has not evaluated these features for safety and effectiveness:    Notifications via email feature; AIC alarm color on case tile feature; Sort case tiles by AIC alarm color feature; Pump metric display on case tile feature

## Distribution

Domestic distribution nationwide.

## Key facts

- **Recall number:** Z-0636-2024
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-06
- **Report date:** 2024-01-10

- **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-0636-2024

## Citation

> AI Analytics. FDA recall Z-0636-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0636-2024. Source: US FDA. Licensed CC0.

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