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 Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Abiomed Europe GmbH Impella Introducer Kits [including Oscor Introducer Kit 14Fr x 13 and 25 cm. REF 0052-3025, as part of Impella CP SmartAssist Pump Set, REF 0048-0014; Oscor Introducer Kit, 23Fr x 6 cm, REF 0052-3006, as part of Impella 5.5 Accessory Kit, REF1000362, Impella 5.0 Accessory Kit, REF004680-AU-ACC, Axillary Insertion Kit, REF0052-0011-EU; Introducer Kit, 14Fr x long Pkgd, REF 0052-0017; 14 Fr Introducer Kit, REF 0052-0001; Multiple batch and serial numbers] [HKMD No.: 180163].
According to TGA, through internal investigation during incoming inspections, the manufacturer has confirmed <0.6 % occurrence of holes in the outer sterile pouch of the Impella Introducer Kits. These holes can compromise the sterile barrier. This type of packaging damage found is isolated to the outer pouches. Non-sterile introducer kits can expose patients to the possibility of the introduction of micro-organisms into the vasculature, leading to an infectious process, bacteraemia or sepsis. This may result in the need for medical intervention, may potentially lead to permanent injury or impairment or in some cases to life-threatening conditions.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-01042-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 7 Dec 2023