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 Thrombectomy Catheter [Reference number: A4558; Lot number: SST1056; Expiry date: 2027-08] [HKMD No.: 220141].
According to the TGA, it has been reported that during the use of the Syntel Silicone Thrombectomy Catheter, the guide tip (not the balloon or catheter) can become damaged and result in the tip detaching.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00295-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 15 Apr 2024