Medtronic Issues Class I Recall for Over 210,000 External Drainage Devices in China Due to Infection Risk
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Recently,Medtronic (Shanghai) Limited reported that due to the risk of cracks or leaks caused by over-tightening of the three-way valve, which could lead to infection, the manufacturer Medtronic Inc. has decided to initiate a voluntary recall of its external drainage and monitoring systems (later changed to external drainage devices).This recall is classified as a Class I recall, meaning that the use of the device may pose a risk of serious injury or death.
According to the report,The product names involved are the External Drainage and Monitoring System (External Drainage Device), with registration or filing certificate codes of National Medical Device Registration Import 20163145109 and National Medical Device Registration Import 20163665109, respectively.The device is manufactured by Medtronic and represented in China by Medtronic (Shanghai) Limited.
The external drainage device has a wide range of applications. It can be used in selected patients to drain and monitor cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space to reduce intracranial pressure, monitor CSF characteristics, and provide temporary external CSF drainage in patients with infected CSF shunts. Additionally, it can be used to monitor intracranial pressure in selected patients with specific conditions.
This recall involves regions and countries worldwide, with a total of 229,132 units recalled. The models and specifications affected are 46700 and 46705, produced after January 20, 2020. Among these, 214,183 units were sold in China.
The reason for the recall is that Medtronic received customer complaints reporting cracks and/or leaks in the three-way stopcock associated with the Exacta External Drainage and Monitoring System. Analysis suggests that over-tightening the three-way stopcock may cause cracks or leaks, compromising the integrity of the drainage system. Failure to perform pre-use checks as per the instructions for use may lead to an increased risk of infection. To date, three adverse events related to patient infections have been reported.
In order to address this issue, Medtronic (Shanghai) Management Co., Ltd. has taken active measures. They will send a "Medical Device Voluntary Recall Notice" to affected customers, informing them of the potential current issues and providing usage training to ensure customers understand the key points of inspection. At the same time, they will also request customers to return a signed Customer Confirmation Letter to confirm receipt of the notice and awareness of the associated risks.
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