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MEDICAL DEVICE RECALLCRITICAL
Abiomed Automated Impella Controller
Abiomed is recalling Automated Impella Controllers due to a potential delay in the "Purge System Blocked" alarm.
What to do
Contact your healthcare provider or Abiomed representative for instructions on software updates or operational guidance to mitigate the alarm delay risk.
Why it was recalled
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.
How to identify it
UPC 00813502011272 00813502011289 00813502011296 00813502010022 00813502010961 00813502010978 00813502012958 00813502012217
Official source
Other recent recalls from Abiomed, Inc.
Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification