Dive Brief:
- Medtronic has recalled systems for draining fluid from the brain because of the risk of cracks and leaks, the Food and Drug Administration said Monday.
- The agency published the Class I notice about Medtronic’s Becker and Exacta external drainage and monitoring system after learning of 15 reported injuries. Affected devices could cause leaks of cerebrospinal fluid, infections and death, the FDA said.
- Medtronic is keeping the devices on the market but asking providers to check their stopcocks and connections for visible cracks. Providers that find cracks or leaks should return the device to Medtronic.
Dive Insight:
Medtronic’s Becker and Exacta devices provide complete closed systems for draining cerebrospinal fluid from the brain. The devices also enable healthcare professionals to monitor fluid pressure and flow rate. Stopcocks and connections facilitate the flow of the fluid.
The FDA’s recall notice describes the risk of cracks and leaks in the device stopcocks. Medtronic wrote to customers in November after receiving customer complaints about the stopcocks, which may be in three different parts of the drainage system depending on its configuration.
No patients are reported to have died because of cracks or leaks, the FDA said, but the potential for serious injury and death led the agency to classify the recall as the most serious type. When Medtronic wrote to customers in November, it said three adverse events associated with patient infection had been reported.
Medtronic has advised providers to monitor all patients for signs of infection, as is recommended on the product labeling, and continue to monitor individuals if a system is found to have cracks or leaks during use. Faulty devices should be replaced using sterile technique, the company said.
The FDA and Medtronic have also provided advice on how to prevent leaks from happening. Providers should check all device fittings are tight and free from leaks, the company said, but only finger tighten connections. Overtightening connections can cause cracks and leaks, Medtronic said.
