Recall of Automated Impella Controllers by Abiomed Due to Purge Failures
Abiomed has issued a recall, classified by the US FDA as the most serious type, for all global Automated Impella Controllers due to purge cassette recognition issues. These failures stem from problems with the purge flag component within the purge pressure sensor assembly, which can cause alarms such as Purge Disc Disconnected or Purge Disc not Detected. This can lead to prolonged delays in mechanical circulatory support, setup delays, or interruptions during ongoing support, and has been associated with serious injuries and deaths.
While awaiting service and replacement of the affected components by Abiomed's field service team, current hospital inventory may continue to be used to ensure continuity of care. Users are advised to follow instructions for use by reinserting the purge disc if an alarm occurs, and switching to a backup controller if the alarm persists. Facilities must also ensure proper cleaning with mild detergent to avoid plastic component damage and perform annual routine preventive maintenance.
Key points
- Abiomed is removing Automated Impella Controllers globally due to purge flag component failures within the purge pressure sensor assembly.
- Failures can trigger alarms during setup or active support, potentially causing serious delays in mechanical circulatory support.
- Current hospital inventory can be used for continuity of care while awaiting scheduled replacements by Abiomed.
- Clinicians should reinsert the purge disc during alarms and switch to a backup controller if the alarm does not clear.
What it means for you
Clinicians and hospital staff utilizing mechanical circulatory support devices should be aware of this Class I recall regarding Automated Impella Controllers. Healthcare providers must follow troubleshooting steps for purge alarms and maintain backup controllers readily available while coordinating with manufacturers for component replacements. As this is an international safety alert, clinical teams in Pakistan should check with local suppliers and the Drug Regulatory Authority of Pakistan (DRAP) regarding the presence and management of affected device inventory.
Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.