Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Abiomed, Inc. Impella 5.5 with SmartAssist heart pump [HKMD No.: 210382].
According to the MHRA, the manufacturer has identified the issue of purge fluid leaks from the purge sidearm related to the Impella 5.5 with SmartAssist pump.
According to the manufacturer, if a purge leak occurs, initially the system will experience low purge pressures, prompting alarms and requiring evaluation of the system. If a temporary solution to the leak is available and the pump continues to work during the time support is needed, there is no harm to the patient. In the event that the issue is not resolved, it may lead to persistent low purge pressure and purge flow and will eventually lead to pump stop and loss of therapy.
For further information, please visit https://mhra-gov.filecamp.com/s/d/zDpGZB2yj7c7m1py
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 May 2023