HIGH

Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller,...

Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

Quick Facts at a Glance

Recall Date
February 16, 2026
Hazard Level
HIGH
Brand
Abiomed

Hazard Information

Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.

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: E-Mail

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Full Description

Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 7. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 8. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 9. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU.. Reason: Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.. Classification: Class I. Quantity: 62 units. Distribution: International distribution in the country of Australia, Canada, France, Germany, Kuwait.

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Brand
Abiomed
Model Numbers
All products below with software version 8.2.2 through 8.5 are affected. 1. Product Code: 0042-0000-CA
GTIN: 00813502011272
Serial Numbers: IC2035
IC9416. 2. Product Code: 0042-0000-EU
GTIN: 00813502011289
+15 more
Report Date
April 8, 2026
Recall Status
ACTIVE

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