Critical Alert
Abiomed Recalls Automated Impella Controller (AIC) with the below product
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-2238-2026Medical Device
Abiomed Recalls Automated Impella Controller (AIC) with the below product
Abiomed, Inc. · Class I — Most Serious
Product Description
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.
Reason for Recall
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.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Denmark, France, Germany, Italy, Kuwait, Netherlands, Norway, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class I recall — the most serious classification reserved for situations where there is a reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death. Abiomed, Inc. initiated this recall of medical device on January 17, 2011 affecting 625 units. 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. The product was distributed internationally, including the United States. Consumers who have this product should stop using it immediately and contact the recalling firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Electric Shock Hazards and Abiomed recalls.