FDA-Device2026-04-08Class IPROCESSING DEFECT
Abiomed Impella Controller recalled for delayed alarm display with Impella 5.5 pumps
OTHERNationwide distribution
Check your Impella Controller serial number
Abiomed's Impella Controller may display a delayed "Purge System Blocked" alarm when used with first-generation Impella 5.5 pumps. This could prevent timely detection of a blocked purge system. The issue affects 62 controllers with specific serial numbers in software versions 8.2.2 through 8.5.
- Check if your Impella Controller serial number matches the FDA recall list (serial numbers starting with IC followed by numbers)
- Contact Abiomed or your healthcare provider immediately if you have an affected unit
- Do not use the device until you receive guidance from Abiomed
Hazard
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.
Sold states
International distribution in the country of Australia, Canada, France, Germany, Kuwait.
Affected count
62 units
Manufactured in
22 Cherry Hill Dr, Danvers, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1591-2026More Abiomed, Inc. recalls
- FDA-Device2026-06-03Abiomed Impella Controller recalled for alarm failures and cassette misalignment
- FDA-Device2026-06-03Abiomed Impella Controller recalled for hardware defects affecting motor control and device function
- FDA-Device2026-04-08Abiomed Impella Pump Set purge cassettes recalled for increased leak risk
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