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 LeMaitre Vascular Inc Syntel Silicone Over the Wire Embolectomy Catheter [Reference numbers: A4E04 and A4E09; Lot numbers: PYT1025 and PYT1072] [HKMD No.: 220141].
According to the TGA, a customer reported being confused about the actual size of the catheter. The labelling for the catalog number and corresponding French size was confusing because the OD symbol should be 5F for all models.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01254-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Sep 2022