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The Penumbra JET 7 Xtra Flex is a reperfusion catheter. A reperfusion catheter is a small tube that’s inserted into the brain and used to extract thrombus – or blood clots – from stroke patients.
The Penumbra JET 7 Xtra Flex catheters are marketed as being more flexible than other reperfusion catheters. However, this flexibility appears to have affected the structural integrity of the device. Doctors, surgeons, and catheter recipients have indicated that the distal tip of the catheter has broken off while the device is used.
Medical reports have indicated that sometimes the tool malfunctions resulting in the distal tip breaking off inside the patient’s blood vessel or the tip expanding and/or ballooning larger than the width of the containing vessel resulting in rupture or a leak in the blood vessel. These issues may result in severe bleeding on the brain, stroke, and even death.
On July 27, 2020, the FDA prompted Penumbra to issue a “Notification to Healthcare Providers” with information about additional warnings and precautions when using the device.
On August 31, 2020, the FDA supplemented the notice to include a warning against using contrast injection through the device.
The company’s recall comes months after issues were first identified by the FDA.
Penumbra issued an urgent and voluntary recall for its defective Xtra Flex catheters on December 15, 2020, citing a “ risk of unexpected death or serious injury while used for removing clots in stroke patients.”
Only after the FDA formally asked the manufacturer to remove the device from the market was the voluntary recall issued.
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