Automated Impella Controllers recalled over alarm, power and purge cassette faults
Automated Impella Controllers sold outside the US are being recalled over alarm failures, power-path faults, electrical-short risks, inaccurate motor-current sensing and purge cassette misalignment.
- 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
- Category
- Medical Device
- Distribution
- Distributed nationwide