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 Invatec S.p.A. Mo.Ma.Ultra [Product number: MOM0130069X6; MOM0130068X5] [HKMD No.: 090188].
According to the MHRA, the Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery proximal balloon and external carotid artery distal balloon inflation and deflation ports.
Both sides of the complaint units’ manifold were labelled with the superior label leading to an incorrect identification of the proximal and distal inflation/deflation ports when viewing the devices from the inferior side.
As this device is used in the carotid space there is the potential for embolism, occlusion/ischemia, and vessel perforation/rupture/blood loss.
For further information, please visit https://mhra-gov.filecamp.com/s/d/26aQPU6IDIqUK9ya
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Oct 2023