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FDA: Marketing Materials Encouraged Neurovascular Catheter Misuse

 
• By Elizabeth Orr

Some manufacturers may be suggesting their guide catheters can be used to remove thrombus – an off-label use that could cause hemorrhage and other adverse events, FDA says.

Misinformation in some neurovascular catheter marketing materials could pose a risk to patients, US FDA said in a March 1 letter to providers.

The letter clarifies indication-for-use differences between neurovascular thrombus retrieval catheters and neurovascular guide catheters, both 510(k) devices. FDA has cleared thrombus retrieval catheters to remove thrombus or restore blood flow...

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