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 Arrow International LLC Arrow AutoCAT Intra-Aortic Balloon Pump (IABP) Series; AC3 Series IABP System [HKMD No.: 210465].
According to the MHRA, the manufacturer has initiated a voluntary Field Safety Corrective Action (FSCA) for the product codes referenced above due to a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. These IABP devices can be powered either by connecting to an AC power source or with battery power for mobile use.
When operating the IABP device using battery power, the expected duration of pumping, after a full charge, is 90 minutes. However, Teleflex has received complaints reporting that some users of the affected IABP devices have experienced short battery run-times, including loss of power during use.
For further information, please visit https://mhra-gov.filecamp.com/s/Yjz4abaReYhx2yIq/d
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 Nov 2022