Penumbra JET 7 Catheters with Xtra Flex Technology (JET 7 Xtra Flex) commonly used during thrombectomy procedures to remove blood clots in stroke patients have been recalled due to complications that may result in serious patient injury or death. If you or someone you love has been adversely affected by JET 7 Xtra Flex Catheter complications, such as ballooning, expansion or rupture of the distal tip during surgery, you may be entitled to financial compensation through a JET 7 Xtra Flex Catheter lawsuit. Consult a knowledgeable product liability lawyer as soon as possible to discuss your legal rights.
In response to the 2020 Penumbra JET 7 Xtra Flex Catheter recall, product liability lawyers across the country are now reviewing cases on behalf of stroke patients who suffered an injury allegedly caused by the recalled medical devices and the loved ones of patients who died as a result of alleged JET 7 Xtra Flex Catheter complications. Among the potential complications or malfunctions that have been linked to Penumbra’s JET 7 Xtra Flex Catheters are: ballooning, expansion, breakage or complete separation, and exposure of the internal support coils near the distal tip region of the catheter during blood clot removal.
The FDA has already received more than 200 reports of malfunctions, injuries and deaths related to the recalled JET 7 Xtra Flex Catheters. Many of these reports describe situations in which the distal tip of the catheter expanded or broke apart during use, resulting in injuries such as brain bleeds, stroke and even death. Medical device makers are responsible for the safety of their products and should be held accountable for any injuries or deaths related to device defects, which is why many stroke patients and the loved ones of those who underwent a thrombectomy procedure involving the JET 7 Xtra Flex Catheter are now pursuing legal claims against Penumbra.
• Blood vessel damage
• Hemorrhage
• Arterial rupture
• Brain bleeds
• Stroke
• Death
“Penumbra JET 7 Catheters with Xtra Flex Technology (JET 7 Xtra Flex) commonly used during thrombectomy procedures to remove blood clots in stroke patients have been recalled due to complications that may result in serious patient injury or death.”
History of Penumbra’s JET 7 Xtra Flex Catheter
Penumbra’s JET 7 Xtra Flex Catheter had been on the market for just about a year when the FDA began receiving reports of device malfunctions, injuries and deaths. In December 2020, Penumbra issued an Urgent Voluntary Medical Device Recall Notification indicating that the company was “voluntarily recalling all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex).” According to the recall announcement, the JET 7 Xtra Flex catheter may become susceptible to distal tip damage during use, which in combination with pressurization or contrast injection, may cause vessel damage in patients possibly leading to serious injury or death.
This notification followed a prior Notification to Healthcare Providers issued in July 2020, in which Penumbra warned that the company had received reports of distal tip expansion or rupture affecting JET 7 Xtra Flex Catheters used during injection of contrast media. At the time the recall notification was issued in December 2020, Penumbra was aware of 17 adverse events involving injuries to patients and 14 events involving patient deaths related to distal tip damage, including damage related to expansion or rupture of the distal tip following contrast injection.
Penumbra JET 7 Xtra Flex Catheter lawsuits include allegations that:
• Penumbra manufactured a defective and unreasonably dangerous medical device,
• Penumbra knew or should have known that its JET 7 Xtra Flex Catheters were prone to failure,
• Penumbra continued selling the catheters despite the risk of serious injury or death, and
• Penumbra failed to provide adequate side effect warnings for patients and surgeons.
Penumbra’s JET 7 Xtra Flex Catheter is part of the Penumbra System, designed to be used with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing to remove blood clots and restore blood flow in the brain of patients experiencing an ischemic stroke. An ischemic stroke occurs when an artery that supplies blood to the brain becomes blocked by a blood clot, which reduces the flow of blood and oxygen to the brain. The JET 7 Xtra Flex Catheter was meant to be inserted into the artery at the patient’s wrist or groin and guided to the blocked artery, where the catheter used suction to remove the clot. Unfortunately, it has since been discovered that the catheters may have been susceptible to damage during use, which put patients undergoing thrombectomy procedures at serious risk. Penumbra’s JET 7 Xtra Flex Catheter was approved in June 2019, about a year and a half before the medical device was recalled.
In December 2020, Penumbra issued an Urgent Voluntary Medical Device Recall Notification
