Abiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
Abiomed is recalling Impella Optical Controllers because a purge flag component may fail, causing recognition issues. The recall covers 4,100 units distributed in the US and internationally.
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 hazard is a functional defect (purge cassette recognition) rather than a direct safety hazard like fire or toxic exposure, and no injuries or illnesses are reported.
Plain-English summary
Abiomed, Inc. is recalling the Impella Optical Controller, Automated Impella Controller, and Impella Connect Package. The recall is due to a potential failure of the purge flag component within the purge pressure sensor assembly, which may result in purge cassette recognition issues.
The recall affects 4,100 units, including 2,785 units distributed in the United States and 1,315 units distributed outside the US. The products were distributed nationwide in the US and to numerous international markets, including Canada, the United Kingdom, Germany, Japan, and Australia.
No specific consumer actions are detailed in the source text beyond the identification of the affected product codes and serial numbers. Healthcare providers and facilities should verify their inventory against the provided product codes and serial number lists to identify affected units.
The recalled product
- Product
- Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 2. Optical, AIC, Impella Connect, Packaged, CA; Produ
- Manufacturer
- Abiomed, Inc.
- Category
- Medical Device — Cardiac Support
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. Optical
- AIC
- Impella Connect
- Packaged
- AU
- Product Code: 0042-0040-AU
- UDI-DI: 00813502012972
- Serial Numbers: IC12674
- IC12675
- IC13066
- IC10162
- IC10163
- IC10387
- IC10388
- IC10747
- IC10748
- IC11472
- IC11487
- IC11489
- IC11490
Distribution
Distributed nationwide across the United States.
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