Quick Facts at a Glance
- Recall Date
- October 1, 2025
- Hazard Level
- HIGH
- Brand
- Abiomed
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Abiomed
- Product type
- Automated Impella Controller (AIC)
- Model numbers
- 0042-0000-AU, 0042-0000-CA, 0042-0000-EU, 0042-0000-EU-L, 0042-0000-IN, 0042-0000-JP, 0042-0000-JP-L, 0042-0000-UK +24 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 1, 2025
Reported by FDA DEVICE
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Impella Controller is used to manage left heart support devices during critical cardiac procedures. The device is managed by clinicians in hospital settings.
Why This Is Dangerous
Cybersecurity vulnerabilities in the operating system could affect device reliability and patient safety.
Industry Context
This recall is part of broader concerns about cybersecurity vulnerabilities in medical devices, with heightened focus on hospital networked systems.
Real-World Impact
Hospitals may delay procedures or replace equipment; patients could experience device-related interruptions.
Practical Guidance
How to identify if yours is affected
- Check device labels for product codes listed in the recall.
- Cross-check serial numbers with Abiomed notices.
- Review hospital procurement records for affected units.
Where to find product info
Official recall notices and device labeling on the manufacturer's site and FDA enforcement reports.
What timeline to expect
Remedies typically take weeks to months depending on replacement availability.
If the manufacturer is unresponsive
- Escalate to hospital risk management.
- File a complaint with the FDA if the manufacturer is unresponsive.
How to prevent similar issues
- Verify device software and cybersecurity updates.
- Institute network segmentation and device isolation in hospitals.
- Ask distributors for recall status before accepting devices.
Documentation advice
Keep all recall communications, serial numbers, and replacement orders for records.
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Product Details
Product: Automated Impella Controller (AIC) and related optical controllers. Class I recall. Quantity: 10,153 units. Distribution: Nationwide in the U.S. and international. Product codes span 0042-0000 series, 0042-0010 series, 0042-0040 series, plus 1000201 and 1000432.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- Worldwide distribution to numerous countries
- Class I recall
- Product Codes: 0042-0000-AU, -CA, -EU, -EU-L, -IN, -JP, -JP-L, -UK, -UK-L, -US, -US-L, -0010-AU, -EU
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Safety Guide
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