Medical device manufacturer, Abbott, has issued a medical device safety alert concerning its Amplatzer TorqVue LP (TVLP) System (80cm) [Model 9-TVLP4F90/080; Lot: 7406296; GTIN: 00811806011578].
According to the manufacturer, the affected device was packaged with a 60cm delivery catheter rather than the intended 80cm delivery catheter as indicated by the packaging label. Due to the shorter length of the catheter, use of the affected product may result in difficulty establishing deployment positioning leading to a potential delay in procedure.
The manufacturer advised affected users to identify, quarantine and return the affected products.
According to the local supplier, the affected products are NOT distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 March 2021