Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its INLIVEN Cardiac Resynchronization Therapy Pacemaker (CRT-P) [Model number: W275; Serial number: 301489].
This medical device safety alert provides important labeling information about one Boston Scientific INLIVENTM CRT-P distributed in Italy. Label diagrams on the outer shipping box and inner tray packaging of the affected device incorrectly describe the location of lead ports on the device header. The correct lead port locations are etched on the case of the pacemaker and are visible at implant. The Physician Technical Manual is also correct.
According to the manufacturer, the device is being retrieved and returned to the manufacturing facility
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 18 January 2017