Abiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
Abiomed is recalling 5,232 Automated Impella Controllers because a purge flag component may fail, causing recognition issues.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences. The source text describes a functional defect (purge cassette recognition) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Abiomed, Inc. is recalling 5,232 units of the Automated Impella Controller (AIC) due to a potential defect in the purge pressure sensor assembly. The recall affects six product variations, including units packaged for the US, Canada, EU, India, Japan, and the UK.
The defect involves the failure of the purge flag component, which can lead to purge cassette recognition issues. The affected units were distributed nationwide in the United States and internationally to numerous countries, including Canada, the United Kingdom, Germany, France, Japan, and Australia.
Healthcare facilities and distributors should check their inventory for the specific serial numbers listed in the FDA recall notice Z-3148-2026. If a unit is affected, it should be removed from service and returned to Abiomed for inspection or replacement.
The recalled product
- Product
- Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, IN; Product C
- Manufacturer
- Abiomed, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Impella Controller
- Packaged
- CA
- Product Code: 0042-0000-CA
- UDI-DI: 00813502010022
- Serial Numbers: IC1324
- IC1346
- IC1480
- IC1481
- IC1543
- IC1544
- IC1572
- IC1595
- IC1598
- IC1664
- IC1665
- IC1715
- IC1769
- IC1790
- IC1791
Distribution
Distributed nationwide across the United States.
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