Abiomed Automated Impella Controller Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Abiomed, Inc. is recalling 10,297 units of the Automated Impella Controller due to a potential software error when used with left ventricular Impella devices. The Class I recall affects devices worldwide.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 3, 2026 and geographically references Worldwide. 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, MedicalDevices.
What Happened
Abiomed, Inc. initiated a voluntary recall of the Automated Impella Controller (AIC) due to a potential software error when used in conjunction with left ventricular Impella devices.
Which Products Are Affected
The recall covers 10,297 units of the Automated Impella Controller and related variants distributed worldwide, including US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom. Affected products include:
- Impella Controller, Packaged, AU (0042-0000-AU)
- Impella Controller, Packaged, CA (0042-0000-CA)
- Impella Controller, Packaged, EU (0042-0000-EU)
- Impella Controller, Packaged, IN (0042-0000-IN)
- Impella Controller, Packaged, JP (0042-0000-JP)
- Impella Controller, Packaged, UK (0042-0000-UK)
- Impella Controller, Packaged, US (0042-0000-US)
- Impella Optical Controller variants (0042-0010 series)
- Optical AIC w/Impella Connect variants (0042-0040 series) All units with software versions 6.0.1, 6.0.2, 6.0.3, 7.1 and above. Specific GTINs and serial numbers are listed in FDA recall Z-2360-2026.
What You Should Do
Consumers and healthcare providers should follow instructions provided in the firm's notification letter regarding the affected devices.
Why This Matters
This Class I recall involves a potential software error in a device used for left heart support, affecting over 10,000 units distributed globally.
Source
FDA recall number Z-2360-2026. https://www.fda.gov
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 (1,821 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.