Penumbra JET 7 Xtra Flex Catheter Recall Lawsuit
The FDA announced on December 15, 2020 that Penumbra was recalling all units of its Jet 7 Xtra Flex Catheter after receiving over 200 reports of serious malfunctions, injuries, and deaths linked to the device. Call GoldenbergLaw today at (800) 504-0281 for a free Penumbra Jet 7 Catheter lawsuit consultation.
Every year, thousands of Americans undergo thrombectomy operations to remove dangerous blood clots from their brains. Catheters such as the popular Penumbra JET 7 Xtra Flex are inserted into the patient to suction out blood clots from the brain and restore normal blood flow. However, reports have demonstrated that the distal tip of the JET 7 Xtra Flex catheter can expand or fracture during the thrombectomy procedure. This device failure can result in injuries such as brain bleeds, hemorrhagic strokes, and even death. Since the Penumbra JET 7 Xtra Flex catheter was introduced to the U.S. market in July 2019, there have been 12 reported deaths relating to procedures where the device was used.
Did you or a loved one undergo an operation to remove a blood clot and come out with a brain bleed? The Defective Catheter Attorneys at GoldenbergLaw are currently investigating cases where an individual has suffered a stroke or brain bleed during a thrombectomy procedure in which a Penumbra Jet 7 Xtra Flex catheter was used. Contact us today for a free Penumbra Jet 7 lawsuit consultation.
Case Quick Facts
What Does a Penumbra JET 7 Xtra Flex Catheter Do in a Thrombectomy Procedure?
A suction thrombectomy procedure removes blood clots from a patient’s brain by suctioning out the clot utilizing a catheter inserted into the patient’s wrist or groin and then guided to the clot in the brain. It is imperative that the blood clot is removed, because blood clots can disrupt the normal flow of blood throughout the body if left untreated. This can cause fatal conditions such as thrombotic strokes.
Penumbra Jet 7 Xtra Flex Catheter Recall
On December 15, 2020, the Food and Drug Administration (FDA) announced that Penumbra recalled all versions of the Xtra Flex Catheter and Jet 7MAX delivery device. The Penumbra Jet 7 recall was announced after over 200 reports were submitted to the FDA documenting device malfunctions that in some cases led to serious injuries and deaths. The agency found that the distal tip of the device was susceptible to balloon, rupture, or break when exposed to pressure during thrombectomy procedures, resulting in severe damage to blood vessels and causing serious injuries and even death.
Surgeons have reported that when they used the Penumbra JET 7 Xtra Flex catheter to remove blood clots from their patients’ brains, the catheter’s distal tip would suddenly expand or fracture. In situations involving catheter expansion, the surgeons noted that this product failure resulted in the catheter expanding like a balloon within an artery in the patient’s brian. The distal tip’s expansion can be multiple times the diameter of the person’s artery which can result in the blood vessel rupturing. A ruptured blood vessel can cause massive bleeding in the brain that may result in hemorrhagic stroke or even death. In situations involving catheter fracture, surgeons noted that the distal tip broke off during the operation. This fracturing of the device can result in the detachment of the broken portion of the catheter within the patient’s artery. The detachment often causes serious injuries that require medical interventions to find and remove the detached distal tip.
The main injuries resulting from Penumbra JET 7 Xtra Flex product failure are:
- Brain bleeds
- Hemorrhagic strokes
Penumbra, Inc. is a global medical device company headquartered in Alameda, California. The company focuses on innovative therapies by designing, developing, manufacturing, and marketing products addressing a variety of medical conditions. Penumbra’s products are sold to hospitals and healthcare providers worldwide.
Penumbra has designed multiple generations of aspiration catheters since 2007. Penumbra’s aspiration catheters became so widespread from 2007 through 2018 that 80% of all suction thrombectomy procedures performed in the United States used Penumbra aspiration catheters. Even now, Penumbra’s aspiration catchers are used in almost 65% of the 45,000 to 50,000 suction thrombectomy procedures that occur annually in the United States.
GoldenbergLaw Can Help
GoldenbergLaw is currently investigating cases where an individual has suffered harm such as a stroke or brain bleed after a procedure in which a Penumbra JET 7 Xtra Flex catheter was used. Our firm has over thirty years of litigation experience, and we will provide you with the Gold standard advocacy that you deserve. Contact us today for a free Penumbra catheter recall lawsuit consultation.
MAUDE Database Death Reports
The U.S. Food and Drug Administration (FDA)’s Manufacturer and User Facility Device Experience (MAUDE) database has already listed 12 entries of deaths occurring in 2019 and 2020 where individuals suffered from harm after operations involving the JET 7 Xtra Flex catheter. The MAUDE database reported that these complications occurred as a result of either the catheter expanding or the device’s distal tip fracturing. Eight of the 12 death reports mentioned that at least one arterial rupture occurred. Many of the arterial ruptures that occurred were in the internal carotid artery which provides blood to the brain and eyes.