Reported Oct 15, 2025 · Ongoing
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding…
Abiomed, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 22 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes
32 of 32 products
| Model / number | Product as published |
|---|---|
0042-0000-AU. | Impella Controller, Packaged, AU |
0042-0000-CA. | Impella Controller, Packaged, CA |
0042-0000-EU. | Impella Controller, Packaged, EU |
0042-0000-EU-L. | Impella Controller, Packaged, EU, Loaner |
0042-0000-IN. | Impella Controller, Packaged, IN |
0042-0000-JP. | Impella Controller, Packaged, JP |
0042-0000-JP-L. | Impella Controller, Japan, Loaner |
0042-0000-UK. | Impella Controller, Packaged, UK |
0042-0000-UK-L. | Impella Controller, UK, Loaner |
0042-0000-US. | Impella Controller, Packaged, US |
0042-0000-US-L. | Impella Controller, Packaged, US, Loaner |
0042-0010-AU. | Impella Optical Controller, Packaged, AU |
0042-0010-EU. | Impella Optical Controller, Packaged, EU |
0042-0010-EU-L. | Impella Optical Controller, EU, Loaner |
0042-0010-IN. | Impella Optical Controller, Packaged, IN |
0042-0010-UK. | Impella Optical Controller, Packaged, UK |
0042-0010-UK-L. | Impella Optical Controller, UK, Loaner |
0042-0010-US. | Impella Optical Controller, Packaged, US |
0042-0010-US-L. | Impella Optical Controller, US, Loaner |
0042-0040-AU. | Optical, AIC, Impella Connect, Pkgd, AU |
- Lot codes and dates
32 of 32 products
Products covered by this recall Model / number Product as published 813502010886Product Code: 0042-0000-AU; ; All Serial Numbers. 813502011272Product Code: 0042-0000-CA; ; All Serial Numbers. 813502011289Product Code: 0042-0000-EU; ; All Serial Numbers. 813502011289Product Code: 0042-0000-EU-L; ; All Serial Numbers. 813502011418Product Code: 0042-0000-IN; ; All Serial Numbers. 813502010428Product Code: 0042-0000-JP; ; All Serial Numbers. 813502010428Product Code: 0042-0000-JP-L; ; All Serial Numbers. 813502011296Product Code: 0042-0000-UK; ; All Serial Numbers. 813502011296Product Code: 0042-0000-UK-L; ; All Serial Numbers. 813502010022Product Code: 0042-0000-US; ; All Serial Numbers. 813502010022Product Code: 0042-0000-US-L; ; All Serial Numbers. 813502010930Product Code: 0042-0010-AU; ; All Serial Numbers. 813502010961Product Code: 0042-0010-EU; ; All Serial Numbers. 813502010961Product Code: 0042-0010-EU-L; ; All Serial Numbers. 813502011425Product Code: 0042-0010-IN; ; All Serial Numbers. 813502010978Product Code: 0042-0010-UK; ; All Serial Numbers. 813502010978Product Code: 0042-0010-UK-L; ; All Serial Numbers. 813502010985Product Code: 0042-0010-US; ; All Serial Numbers. 813502010985Product Code: 0042-0010-US-L; ; All Serial Numbers. 813502012972Product Code: 0042-0040-AU; ; All Serial Numbers. - Amount recalled
- 10,153 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Using this product could cause serious injury, illness or death — stop using it now.
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