Abiomed, Inc. recalls Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product…
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
Read the official notice →- Date
- 2025-10-29
- Country
- United States
- Brand
- Abiomed
- Product
- Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product…
- Classification
- Class I
- Units
- Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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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Increased risk of purge leaks with Generation 1 purge cassettes.
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Abiomed, Inc. recalls Impella RP Flex with SmartAssist. Product Code: 1000323.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of Austria, Canada,…Official notice → - 2026-01-14
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Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Device packaged in incorrect outer box carton.
FDA · DeviceAbiomed, Inc.International distribution to the country of Australia and Taiwan.Official notice → - 2025-10-15
- US
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).
FDA · DeviceAbiomed, Inc.Nationwide distribution. International distribution to United Arab Emirates,…Official notice → - 2025-10-01
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged,…
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or…
FDA · DeviceAbiomed, Inc.US distribution to AR, AZ, CA, CO, CT, FL, GA, ID, MA, MI, MO, MS, NJ, NY, OH,…Official notice → - 2025-08-06
- US
Abiomed, Inc. recalls Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU;…
A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
FDA · DeviceAbiomed, Inc.Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei…Official notice →
Other drugs & medical recalls in the United States
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ICU Medical, Inc. recalls IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set…
IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or…
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B BRAUN MEDICAL INC recalls Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version:…
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