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.
Medical device manufacturer, Abbott Medical, has issued a medical device safety alert concerning its TactiFlex Ablation Catheter, Sensor Enabled (A-TFSE-FJ) [Affected Lots: 10073391, 10075618, 10080798, 10086492, 10087953, 10089624, 10092157, 10093066, 10095363] [HKMD No.: 230237].
The manufacturer is voluntarily recalling 9 lots of the TactiFlex Ablation Catheter, Sensor Enabled (models A-TFSE-FJ). When catheters from these specific lots are used with the EnSite X EP System , the system does not correctly recognize the catheter as the appropriate product model (TactiFlex SE) and instead reads and displays it as the FlexAbility DD model. Because the system incorrectly recognizes the catheter model as the FlexAbility DD model, some features specific to the TactiFlex Ablation Catheter, Sensor Enabled models do not appear on the display (e.g., deflection direction indicator and force vector arrow). The catheter image may also appear inverted on the EnSite X display. This issue, which results in the System incorrectly recognizing the catheter, is isolated to a specific manufacturing error for the lots listed above. This issue occurs when the device is initially plugged into the EnSite X EP System.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Dec 2023