Early Alert: Heart Pump Issue from Abiomed
The FDA has issued an alert regarding specific Impella CP sets that are out of specification. Use of these affected units may result in low purge pressure events starting from the onset of the clinical case.
This alert specifically affects Abiomed, healthcare facilities utilizing Impella CP systems, and clinical staff responsible for managing cardiac pump purge systems.
The occurrence of low purge pressure at the beginning of a case suggests a manufacturing or quality control deviation. This issue could potentially compromise the performance of the heart pump during critical procedures, likely requiring immediate investigation into the affected lot's manufacturing process and a potential field correction or recall.
QA and clinical teams should identify and sequester affected Impella CP sets immediately. Institutions using these systems should monitor for low purge pressure alerts from the start of the procedure and ensure staff are briefed on appropriate mitigation steps.
Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
Open in openFDA / FDA.gov