Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its Amplatzer Vascular Plug II [Model 9-AVP2-010; Lot 7983776; GTIN: 00811806010380 & Model 9-AVP2-016; Lot 7977776; GTIN: 00811806010410].
The manufacturer has identified that 10mm product lot 7983776 was packaged with 16mm Amplatzer Vascular Plug II devices and the 16mm product lot 7977776 was packaged with 10mm devices. According to the manufacturer, the use of an incorrect device size has the potential for a residual shunt or a device embolization and/or protrusion into the adjacent vascular with a potential for causing unintended vascular obstruction of an adjacent vessel.
The manufacturer advised affected users to identify, quarantine and return the affected products. For those patients who have already been implanted with one of the affected devices, it is recommended that the product registration and medical record be updated to reflect the correct model number implanted.
According to the local supplier, the affected product is not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 Oct 2021