# Major Recall Alert: Impella 5.5 With SmartAssist Set, Impella CP Smart Assist Set & Purge Cassette 5 Pack Recalled Due to Increased Risk of Purge Leaks
Abiomed, Inc. has issued an urgent voluntary recall of its **Generation 1 Purge Cassette**, a component used in the **Impella 5.5 With SmartAssist Set**, **Impella CP Smart Assist Set**, and **Purge Cassette 5 Pack**. The recall stems from concerns over an increased risk of purge leaks that could compromise device performance and patient safety. To address this issue, an updated **Generation 2 Purge Cassette** with a lower risk of leaks has been developed.
Here’s what you need to know about this recall and the steps you should take to address it.
## Why This Recall is Important
The Impella devices are life-saving, FDA- and Health Canada-approved medical devices often used in critical care settings to assist in heart function. The **Generation 1 Purge Cassette**, however, has been shown to have an **increased risk of purge leaks**. This could lead to compromised performance of the purge system designed to prevent blood clots or device malfunction.
A potential failure like this is significant as it may impact patient safety and the effectiveness of the Impella heart pump system. For healthcare providers, understanding and addressing this recall is vital to ensure patient well-being and prevent adverse outcomes.
## Details of the Recall
Abiomed, Inc. has taken the following actions to address the situation:
- **Products Affected**:
- Impella 5.5 With SmartAssist Set (includes Generation 1 Purge Cassette)
- Impella CP Smart Assist Set (includes Generation 1 Purge Cassette)
- Purge Cassette, 5 Pack
- **Reason for Recall**: The Generation 1 Purge Cassette has been found to carry an **increased risk of purge leaks**, potentially impacting device performance.
- **Solution**: Abiomed has introduced the **Generation 2 Purge Cassette**, designed to lower the risk of purge leaks and improve overall system reliability.
- **Interim Guidance**: Until the replacement process is complete, Abiomed advises users to:
- **Monitor the Purge System closely**.
- Refer to the **Instructions for Use (IFU)** if a "Purge Pressure Low" alarm occurs.
- **Product Replacement**: Abiomed is actively working to coordinate the removal and replacement of the affected cassettes with the updated version.
For more detailed information, consult the official recall notice here: [Abiomed Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/abiomed-purge-cassette-generation-1-impella).
## What You Should Do
If you are a healthcare provider or facility using the affected products, follow these steps:
1. **Review Inventory**: Check if your inventory includes the Generation 1 Purge Cassette.
2. **Follow Interim Safety Measures**:
- Monitor the Purge System for alarms or irregularities.
- Consult the IFU and take immediate action if a "Purge Pressure Low" alarm occurs.
3. **Contact Abiomed**: Coordinate the removal and replacement of the affected components through Abiomed.
4. **Inform Your Team**: Ensure your medical team understands the interim safety protocols.
## Stay Safe – Get Instant Recall Alerts
Product recalls like this highlight the importance of staying informed about changes that could impact safety and performance. To ensure you never miss critical updates, **download our Recall Alerts App today**. With real-time notifications and comprehensive recall details, you’ll always be one step ahead in safeguarding your patients and your healthcare practice.
Act quickly to address this recall and review Abiomed’s official guidance. For more information, visit the [Abiomed Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/abiomed-purge-cassette-generation-1-impella).
*Your patients rely on you to make informed, safety-first decisions—don’t leave anything to chance. Stay prepared, stay informed, and stay safe.*