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Impella® Controller Recall Due to Abiomed has identified specific automated I...

# Major Recall Alert: Impella® Controller Recalled Due to Underrated Capacitors

Abiomed has issued a critical recall for certain **Impella® Controllers** in Canada after identifying a significant issue with their pump driver circuit assemblies. These assemblies were found to have **25v-rated tantalum capacitors** instead of **35v-rated capacitors**, which do not meet the required specifications. This safety concern could lead to decreased pump performance, abrupt pump stoppage, and critical system failure. The recall, announced on **August 27, 2025**, emphasizes the importance of addressing this defect immediately for the safety of patients relying on this device.

[**Read the official recall notice here**](https://recalls-rappels.canada.ca/en/alert-recall/impellar-controller-0)

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## Why This Recall Is Important

The **Impella® Controller** plays a vital role in cardiac care, particularly in patients requiring mechanical support for severe heart conditions. It is a portable, automated device used to control the Impella® heart pumps. However, the presence of **25v-rated capacitors**—instead of 35v-rated ones—in some units presents a **serious device failure risk**. These underrated capacitors can result in:

- **Decreased pump performance**, potentially impacting patient treatment.
- **Pump stoppage**, which could abruptly disrupt vital blood flow.
- Device alarms sounding, including “**Impella failure**” or “**Impella stopped. Controller failure.**”

These malfunctions could pose life-threatening risks, emphasizing the urgency of the recall. Medical professionals and health facilities across Canada must take immediate action to identify and address the affected units.

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### Details of the Recall

Here are the key details consumers and healthcare providers need to know:

- **Brand**: Impella® Controller
- **Product**: Automated Impella® Controller
- **Recall Reason**: Affected devices contain **25v-rated tantalum capacitors** instead of the required **35v-rated capacitors**, compromising pump function.
- **Potential Issues**: Performance degradation, pump stoppage, or complete device failure with alarm notifications.
- **Recall Start Date**: August 27, 2025
- **Issued by**: Abiomed

If you use or manage this medical device, it is critical to assess your equipment and follow all recall instructions provided by Abiomed to prevent harm to users.

For the full recall notice or additional information, read the government announcement [here](https://recalls-rappels.canada.ca/en/alert-recall/impellar-controller-0).

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### What You Should Do

If you or your medical facility uses the **Impella® Controller**, follow these steps immediately:

1. **Identify affected devices**: Check whether your unit matches the recalled batch by contacting Abiomed or referring to the official recall notice.
2. **Follow recall instructions**: Adhere to the guidance provided by the manufacturer or distributor for repairs, replacements, or other necessary actions.
3. **Stop using defective devices**: To ensure patient safety, cease the usage of recalled Impella® Controllers until further notice.
4. **Contact Abiomed support**: For further details or guidance on handling the recall, reach out to Abiomed customer support directly.

Taking prompt action is critical to mitigate risks and ensure the safety of patients relying on this device for life-saving interventions.

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### Stay Safe – Get Instant Recall Alerts

Recalls like this highlight the importance of staying informed about product updates and safety issues, especially in the medical field. To stay one step ahead, consider downloading a dedicated recall alert app today. Get notifications about recalls in real time and ensure your home, workplace, and tools are always safe and compliant.

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The safety and efficacy of medical devices like the Impella® Controller are paramount. If you own, operate, or rely on this device, act now to avoid potential hazards. Always stay updated on recalls through trusted sources like the official Canadian recall portal.

Stay proactive, stay informed, and stay protected!

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