Impella controllers recalled over purge pressure issues from retainer failures
Abiomed is recalling Automated Impella Controllers over the potential for purge pressure issues caused by purge retainer failures, covering 9,177 distributed units.
- Product
- Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-00
- Category
- Medical Device
- Distribution
- Distributed nationwide