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FDA Recalls Deadly Catheter

The device intended to save lives is linked to 14 deaths and 200 malfunctions.

A recent Daily Hornet article discussed the recall of a catheter that’s prone to damage that can lead to severe injury or death. The device is Penumbra’s JET 7 Reperfusion Catheter with Xtra Flex Technology, and it’s intended for patients experiencing a stroke. However, the FDA has received over 200 reports of adverse events including serious injury and death.

The issues stem from the fact that the catheter’s tip can break off or inflate inside the patient’s brain leading to catastrophic bleeding in the brain and sudden death. The Class 1 recall involves more than 30,000 units that were distributed worldwide between June 2019 and December 2020. The recall comes after months of criticism in the media, where the JET 7 was dubbed a “killer catheter.”

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