Abiomed, Inc. recalls Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1.…
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Read the official notice →- Date
- 2025-10-15
- Country
- United States
- Brand
- Abiomed
- Product
- Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1.…
- Classification
- Class I
- Units
- Nationwide distribution. International distribution to United Arab Emirates,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Abiomed, Inc. recalls Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU;…
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