Abiomed, Inc.: Temporary Non-roller Type Left Heart Support Blood Pump
Recall Summary Abiomed is recalling Automated Impella Controller (AIC) devices sold in the US and multiple other countries due to several electrical and mechanical problems, including alarm failures, power faults, electrical short risks, motor-current sensing errors, and improper alignment that can prevent the purge system from priming correctly. These issues could require medical staff to switch to a backup controller during patient treatment. The recall affects AIC units distributed worldwide across all US states and territories, as well as Canada and multiple European and Middle Eastern countries.
- Recalling firm
- Abiomed, Inc.
- 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.
- 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.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2011-01-17
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/bab63d9f-60f8-4e10-b981-a9501979acba