Heart Pump Correction: Abiomed Issues Correction for Automated Impella Controllers
Abiomed issued a correction for certain Automated Impella Controller (AIC) units requiring hardware updates to mitigate risks of delayed or lost hemodynamic support.
This affects Abiomed, healthcare facilities utilizing Automated Impella Controllers, and clinical staff responsible for managing patients requiring mechanical circulatory support.
The need for hardware updates suggests a potential design or component vulnerability that could lead to device failure during critical care. From a regulatory perspective, this qualifies as a significant field correction. Failure to implement these updates could result in acute clinical risks and increased liability for healthcare providers and the manufacturer if support is interrupted.
QA and clinical engineering teams should identify all in-site Automated Impella Controllers and coordinate with the manufacturer to facilitate required hardware updates. Clinical teams must be briefed on the risks of hemodynamic support delays until updates are completed. Ensure all field correction activities are documented in accordance with 21 CFR 806.
Certain AIC units require hardware updates to address potential safety concerns that could lead to a delay or loss of hemodynamic support.
Open in openFDA / FDA.gov