Quick Facts at a Glance
- Recall Date
- September 16, 2025
- Hazard Level
- HIGH
- Brand
- Abiomed
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- 1000432, 1000201, 0042-0000-US, 0042-0000-CA, 0042-0000-EU, 0042-0000-IN, 0042-0000-JP, 0042-0000-UK +16 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 16, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
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 guide and monitor the Impella heart pump system. It plays a critical role in certain cardiac support procedures.
Why This Is Dangerous
A purge retainer failure can create purge pressure issues, potentially affecting device performance during use.
Industry Context
This recall is not identified as part of a broader industry pattern in the provided documentation.
Real-World Impact
Healthcare providers must halt use of these devices immediately. Patients may require reassessment and alternative support as determined by clinicians.
Practical Guidance
How to identify if yours is affected
- Review product codes on the device label against the recall list
- Check for the affected packaging and country-specific codes
- Verify serial numbers if provided by Abiomed or the recall notice
Where to find product info
Refer to the recall notice and the FDA enforcement page for list of affected product codes and serial ranges
What timeline to expect
Remediation timelines are not specified. Expect communications from Abiomed and healthcare providers within weeks to months
If the manufacturer is unresponsive
- Escalate with your hospital's risk manager
- File inquiries with the FDA if the manufacturer is unresponsive
- Document all contacts and dates
How to prevent similar issues
- Ask for confirmation of device status before use in procedures
- Register for recall notifications from Abiomed or the FDA
- Verify device labels and product codes before deployment
Documentation advice
Keep copies of all recall notices, letters, serial numbers, and correspondences with Abiomed or clinicians
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Product Details
Product: Automated Impella Controller (AIC) and variants. Product Codes include 1000432 (AIC w/Impella Connect for ECP) and 1000201 (Dbl optical, AIC Impella Connect). Packaged controllers include 0042-0000-US and other country codes (CA, EU, IN, JP, UK, AU). Optical AIC and Impella Connect packaging variants listed with codes 0042-0040-XX and 0042-0010-XX. Total distributed units: 9,177 worldwide (822 pending correction). Serial numbers include IC11619, IC11616, IC11611, IC11600, IC11239, IC11238, IC10837, IC10497, IC10493, IC10338, IC10362; corrected as of 09/16/2025: IC11404, IC11401, IC114
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 9,177 total distributed units worldwide
- Hazard: purge pressure issues due to purge retainer failures
- Classification: Class I recall
- Status: ACTIVE as of 2025-10-29
- Remedy: stop use and follow recall instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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