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FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device Anaconda Biomed raises $56M to finish a 327-patient stroke trial FDA issues an early alert on Impella controllers that miss purge cassettes HighLife raises 80 million euros for a mitral valve CE marked in January Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device Anaconda Biomed raises $56M to finish a 327-patient stroke trial FDA issues an early alert on Impella controllers that miss purge cassettes HighLife raises 80 million euros for a mitral valve CE marked in January Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US

Early alert

FDA issues an early alert on Impella controllers that miss purge cassettes

MedDevice Startups Staff · 21 hrs ago · 2 min read · Via FDA

FDA posted an early alert on September 23 covering three Automated Impella Controller configurations from Abiomed: 0042-0000-US, 0042-0010-US and 0042-0040-US.

A retrospective review of servicing records identified controllers that need hardware, firmware or software updates. The listed failures are not recognizing purge cassettes, unreliable buttons during menu selection, unstable startup and software defects. Each can delay therapy or cause a loss of hemodynamic support.

No serious injuries or deaths had been reported as of September 8. FDA says hospitals can keep using inventory while they arrange service with Abiomed, and points facilities to the Abiomed field service team. An early alert is not a classified recall, so the classification can still move.

The trigger here was a look back at service records rather than complaint files. A postmarket surveillance procedure that only mines complaints and MDRs would have missed this signal entirely.

Questions & Answers

Which Abiomed Impella controllers are covered by the September 2026 FDA early alert?

The FDA early alert of September 23, 2026 covers three Automated Impella Controller configurations from Abiomed: 0042-0000-US, 0042-0010-US and 0042-0040-US.

What is wrong with the Abiomed Impella controllers in the FDA early alert?

A retrospective review of Abiomed servicing records identified controllers needing hardware, firmware or software updates. The reported problems are failure to recognize purge cassettes, unreliable buttons during menu selection, unstable startup and software defects, any of which could delay therapy or cause loss of hemodynamic support.

Can hospitals keep using Abiomed Impella controllers during the early alert?

Yes. FDA says hospital inventory can continue to be used while facilities coordinate service with Abiomed. No serious injuries or deaths had been reported as of September 8, 2026.

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