Recently, the Food and Drug Administration issued a manufacturer recall for Penumbra catheters after they were linked to hundreds of injuries and a number of deaths. Penumbra catheters are used to remove brain clots in stroke patients, but reports indicate that the Penumbra JET 7 Xtra Flex catheter may actually cause strokes due to a product defect and resulting malfunction.
In this article, we’ll discuss what is known about the potential Penumbra catheter stroke risk, and what you can do if you or a loved one have suffered a stroke or other injury after being treated with a Penumbra JET 7 Xtra Flex catheter.
If you or a loved one underwent a procedure involving a Penumbra catheter and suffered a stroke or other injury potentially as a result, you may be entitled to compensation.
Please call 1-800-525-7111 today and we will review your claim to find out if you may qualify for a Penumbra lawsuit.
Penumbra JET 7 Xtra Flex Catheter FDA Warning
The FDA urgent recall has linked the Penumbra JET 7 Xtra Flex catheter and the JET 7MAX configuration to an increased risk of death and serious injuries due to device malfunctions. According to the recall, 20 of these reports indicate 14 deaths linked to Penumbra catheters.
Medical providers are urged to immediately stop use of these potentially dangerous catheters.
“Do Penumbra JET 7 Xtra Flex catheters increase stroke risk?”
According to the FDA recall notice, over 200 medical device reports (MDRs) have been filed with the FDA associating the JET 7 Xtra Flex catheter with death and serious injuries. These injuries include:- Stroke (cerebral infarction)
- Blood vessel damage
- Brain bleed (hemorrhage)
- Brain damage
- Coma
- Death
The Penumbra catheter stroke risk is real. Patients who have suffered a stroke potentially due to a defective Penumbra JET 7 Xtra Flex catheter may be entitled to compensation.
For a FREE, no-obligation consultation with an experienced Penumbra catheter lawsuit attorney handling stroke and other injury claims, please call 1-800-525-7111.
You can also complete the fast and easy form below if you prefer.
Please call 1-800-525-7111 and let’s review your claim.
Manufacturer Response to Penumbra Stroke Risk Claims
In response to the reports of increased risk of stroke in patients when doctors used the Penumtra JET 7 Xtra Flex catheter to inject contrast dyes into patients for angiography procedures, Penumbra stated that “any injection pushed through the catheter may re-introduce clot to the brain arteries which may result in another stroke.”Professional Criticism
However, doctors interviewed by the Foundation for Financial Journalism stated that “there is an expectation that the [aspiration] catheter can withstand an injection.” They also expressed criticism that Penumbra only guaranteed safety for its catheter when paired with other Penumbra devices, which “flies in the face of current medical practice.” More importantly, information directly from the manufacturer indicates that the Penumbra JET 7 Xtra Flex catheter “is not able to withstand the same burst pressures to failure as the manufacturer’s other large bore aspiration catheters used to remove thrombus in acute ischemic stroke patients.” Equipment failure on aspiration catheters used to remove clots in stroke patients puts patients at a much higher risk of secondary strokes or other injuries. Equipment failures associated with the Penumbra JET 7 Xtra Flex catheter may include:- Ballooning
- Expansion
- Rupture
- Breakage
- Complete separation
“Do I qualify for a Penumbra stroke lawsuit?”
If you or a loved one have suffered a stroke after undergoing a procedure involving a Penumbra JET 7 Xtra Flex catheter, you may qualify for a Penumbra lawsuit. To qualify for a Penumbra injury lawsuit you or a loved one must:- Be <85 years old
- Have suffered one of the following injuries:
- Stroke (cerebral infarction)
- Coma
- Cerebral hemorrhage (brain bleeding)
- Brain damage or blood vessel damage requiring additional surgery or endovascular intervention
- Death
Why Hire Riddle & Brantley for a Penumbra Catheter Stroke Lawsuit?
With more than 220+ years of combined legal experience, the defective medical device attorneys at Riddle & Brantley know how to hold negligent manufacturers accountable.
Potentially negligent medical device manufacturers like Penumbra need to be held accountable for injuries possibly caused by their devices when they do not hold up to the highest standards of care.
With Riddle & Brantley, our consultations come with no obligation. If you decide to hire us to represent you, we will do our best to get you the justice and compensation you deserve.
We’ve recovered more than $500 million on behalf of injured victims over the last 20 years alone (see disclaimer below), and we are dedicated to ensuring you receive the maximum compensation you are entitled to.
Call 1-800-525-7111 today for a FREE consultation concerning a potential Penumbra catheter stroke claim or other Penumbra injury lawsuit.
There is no obligation and we don’t get paid unless you do. It’s as simple as that. If our injury attorneys don’t recover compensation for you, you won’t pay any attorney fees.
We believe Justice Counts and would love to help you and your loved ones however we can.
*** Disclaimer: The results mentioned are intended to illustrate the type of cases handled by the firm. These results do not guarantee a similar outcome, and they should not be construed to constitute a promise or guarantee of a particular result in any particular case. Every case is different, and the outcome of any case depends upon a variety of factors unique to that case.