Medical device manufacturer, Merit Medical Systems, has issued a medical device safety alert concerning its PreludeSYNC DISTAL Radial Compression Devices [Catalogue Number: A) SDRB-REG-LT; B) SDRB-REG-RT; Lot Number: A) H1559517; H1727668; B) H1666548; H1723973].
The manufacturer is voluntarily conducting a recall of the affected products due to a manufacturing defect. During the sterilization process, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may result in a lack of hemostasis resulting in bleeding or a delay in treatment. The defect is likely to be visually identified by the clinician before use or identified during inflation of the balloon.
The manufacturer has chosen to remove the affected products from the market and requests affected users to immediately stop using the affected lots and return the units to the manufacturer.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 March 2020