Abiomed Automated Impella Controller Recall
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Abiomed, Inc. is recalling 625 units of Automated Impella Controller devices worldwide due to alarm failures, power-path faults, and purge system issues.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 23, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Abiomed, Inc. initiated a voluntary recall for the Automated Impella Controller (AIC) after identifying alarm failures, power-path faults, electrical-short risks, inaccurate motor-current sensing, and improper alignment between the purge cassette and motor drive that can cause piston block events.
Which Products Are Affected
The recall covers 625 units distributed worldwide, including US Nationwide and the countries of Canada, Denmark, France, Germany, Italy, Kuwait, Netherlands, Norway, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and United Kingdom. Affected products include:
- Impella Controller, Packaged, CA (Product Code: 0042-0000-CA, GTIN: 00813502011272)
- Impella Controller, Packaged, EU (Product Code: 0042-0000-EU, GTIN: 00813502011289)
- Impella Controller, Packaged, UK (Product Code: 0042-0000-UK, GTIN: 00813502011296)
- Impella Controller, Packaged, US (Product Code: 0042-0000-US, GTIN: 00813502010022)
Specific serial numbers are listed in FDA recall Z-2238-2026. This is a Class I recall.
What You Should Do
Consumers and facilities should follow instructions provided by Abiomed, Inc. for affected units.
Why This Matters
The identified issues may prevent proper device operation, including the inability to complete priming of the purge system.
Source
FDA Enforcement Report, recall number Z-2238-2026, recalling firm Abiomed, Inc., Danvers, MA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,420 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to June 23, 2026.
Frequently Asked Questions
Common questions about this FDA recall.