Injuries Linked to the Penumbra JET 7 Xtra Flex Catheter Recall
Penumbra JET 7 Xtra Flex Catheter Injuries
On December 15, 2020, the U.S. Food and Drug Administration (FDA) notified the public that Penumbra, Inc. had issued a voluntary recall of their Penumbra JET 7 Xtra Flex catheter due to reports of the product causing serious injuries and even death. The notice warned that all users should stop using the device and instructed all facilities to remove the device from their inventories. The recall came after the FDA received more than 200 medical device reports citing deaths, serious injuries, and device malfunctions of the Penumbra JET 7 Xtra Flex catheter.
Injuries reported include vessel damage, hemorrhage, and cerebral infarction. Product failures include the device ballooning, expanding, rupturing, breaking, completely separating, and/or exposing the internal support coils near the distal tip of the device. The most serious reported complications linked to the Penumbra JET 7 Xtra Flex catheter are hemorrhagic stroke and death.
Hemorrhagic Stroke and Death
A hemorrhagic stroke is also known as a brain bleed and is often caused by a blood vessel that ruptures and bleeds into the brain. The blood then accumulates and compresses the nearby brain tissue causing a stroke due to the bleeding. A hemorrhagic stroke due to rupturing can be the result of a naturally weakened blood vessel in the brain, but it can also be the result of product failure.
Penumbra, Inc.’s recall of the company’s Penumbra JET 7 Xtra Flex product noted that their catheter may be susceptible to damage of the catheter’s distal tip as a result of pressurization or contrast injection. Such distal tip damage, especially if it results in ballooning or expansion of the catheter, can result in severe vessel damage due to the catheter actually being inside the vessel at the time of the device failure.
If the JET 7 Xtra Flex balloons to become many times the size of the vessel itself, the catheter’s dramatic increase in size within the blood vessel can cause the vessel itself to dangerously expand and similarly rupture. Such rupturing could trigger a serious hemorrhagic stroke.
According to the Journal of the Missouri State Medical Association, hemorrhagic strokes have a mortality rate of 51% to 65% depending on the location of the hemorrhage. Only 20% of patients are expected to be independent within six months of suffering such a stroke. Even if a patient who suffers a Penumbra JET 7 Xtra Flex product failure leading to hemorrhagic stroke survives, the road to recovery is long and difficult.
For more on that process, stay tuned for the second blog in this series on the Penumbra JET 7 Xtra Flex catheter recall, “Rehabilitative Care After a Penumbra Catheter Injury”, which will be released next week.
GoldenbergLaw Can Help
If you or a loved one has suffered harm after a procedure involving a Penumbra JET 7 Xtra Flex Catheter, reach out to the Penumbra Catheter Recall Attorneys at GoldenbergLaw today. We have over thirty years of experience with defective medical device cases and will work to give you the Gold standard of advocacy that you deserve. Leave the sleepless nights to us and contact the attorneys at GoldenbergLaw today!