Abiomed, Inc. — Class I: Automated Impella Controller (AIC) with the below product descriptions and corresponding P
Abiomed has initiated a Class I recall for Automated Impella Controllers (AIC) following retrospective identification of alarm failures, power-path faults, electrical shorts, sensing inaccuracies, and improper alignment between the purge cassette and motor drive. These defects can lead to piston block events or failures during the purge system priming process.
Clinicians and hospitals using Abiomed Impella Controllers in the US, EU, UK, and Canada; Abiomed, Inc. QA/RA and manufacturing teams; and patients requiring mechanical circulatory support via these consoles.
A Class I designation signifies the most serious recall level, where the FDA believes there is a reasonable probability of serious adverse health consequences or death. The breadth of the identified issues—ranging from electrical risks to mechanical alignment faults—suggests potential systemic manufacturing or design verification challenges. The requirement for users to switch to backup consoles during critical priming stages carries inherent clinical risks during high-acuity procedures.
QA and clinical teams should verify the inventory of Impella Controller units against the specified product codes for US, UK, EU, and CA markets. Facilities should ensure backup consoles are readily available and staff are trained to identify piston block events or purge system priming failures. Regulatory departments must ensure all retrospective filings and CAPA documentation regarding these findings are robust and aligned with current safety data.
Class I. Reason: Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.. 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, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.. Firm: Abiomed, Inc. (Danvers MA United States). Status: Ongoing.
Open in openFDA / FDA.gov