FDA Says Medtronic Neurosurgery Recalls Duet External Drainage And Monitoring System Catheter Tubing Due To A Potential For The Catheter Disconnection From The Patient Line Stopcock Connectors; FDA Has Identified Medtronic Neurosurgery Recall As A Class I Recall; There Have Been 26 Reported Injuries Related To Medtronic Neurosurgery Recall
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The FDA has classified Medtronic Neurosurgery's recall of its Duet External Drainage and Monitoring System Catheter Tubing as a Class I recall due to the risk of catheter disconnection. This issue has already resulted in 26 reported injuries. The recall highlights a significant safety concern for patients using the device.

March 07, 2024 | 5:49 pm
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Medtronic's Class I recall of its Duet External Drainage and Monitoring System Catheter Tubing due to disconnection risks has led to 26 reported injuries, indicating a significant safety concern.
The classification of the recall as Class I by the FDA signifies the highest level of risk associated with a medical device recall, indicating a situation where there is a reasonable probability that the use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification, coupled with the reported injuries, is likely to have a negative impact on Medtronic's reputation, potentially affecting its stock price in the short term due to concerns over product safety and potential financial liabilities.
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