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 Balt Extrusion SAS HYBRID and SONIC [Reference: HYBRID1214D, HYBRID007D, HYBRID008D, HYBRID008J, HYBRID1214DA, HYBRID007J, HYBRID1214D, SONIC1.2F15/HYBRID007D-KIT, SONIC1.2F25/HYBRID007D-KIT, SONIC1.2F15/HYBRID007D-KIT; Lot number: 00506800, 00506369, 00521942, 00520501, 00514715, 00520500, 00506801, 00524096, 00513093, 00513550] [HKMD No.:210338, 210339].
According to the MHRA, the manufacturer received two complaints related to friction during the use of HYBRID guidewire with MAGIC microcatheters during the post-market surveillance program. No patient injury was observed for the complaint above-mentioned.
The investigation of the returned products confirmed that the products’ dimensions do not match the specifications: the outer diameter of the HYBRID guidewires inside the pouch does not correspond to the outer diameter mentioned on the labels.
The investigation revealed that the cause of these complaints was an isolated human error in production. Confirmation testing is being performed on our remaining inventory to confirm the scope of this issue is limited to the lot subject to this FSN.
For further information, please visit https://mhra-gov.filecamp.com/s/d/3oCkw3wvsVZDyu86
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 Nov 2023