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.
Medical device manufacturer, Abiomed Europe GmbH has issued a medical device safety alert concerning its Impella CP Set with SmartAssist, Impella 5.5 Set with SmartAssist [Product code: 0048-0014, 0048-0047, 0550-0002, 0550-0007, 1000482] [HKMD No.: 180163, 210382].
The manufacturer has identified that there is a risk of optical sensor damage in Impella products when used concurrently and in close proximity with Shockwave Coronary IVL Catheter. Placement Signal Not Reliable alarm may occur and subsequently disable pump position monitoring. Loss of the placement signal does not impact Impella hemodynamic support.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 01 Aug 2024