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MEDICAL DEVICE RECALLCRITICAL
Abiomed Impella Purge Cassette
Abiomed is recalling Generation 1 purge cassettes sold individually and within Impella pump sets due to an increased risk of purge leaks.
What to do
Healthcare providers should immediately stop using the affected Generation 1 purge cassettes and contact Abiomed for further instructions regarding replacement or return.
Why it was recalled
Increased risk of purge leaks with Generation 1 purge cassettes.
How to identify it
UPC 00813502011135 00813502011029 00813502010510 00813502011999 00813502010947 04260113630273 04260113630242 00813502011777
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