If you or a loved one have been seriously injured due to a malfunctioning Penumbra JET 7 catheter, the attorneys at Dickerson Oxton may be able to help. We are currently accepting cases for potential JET 7 catheter lawsuits, call today for a free consultation.
On December 15, 2020 Penumbra, Inc. issued an urgent, voluntary recall of all configurations of the JET 7 Reperfusion Catheter with Xtra Flex technology. The recall states that the catheter may become damaged during use and cause damage to blood vessels, resulting in injury to or death of the patient. The same day, the U.S. Food and Drug administration sent alerts to health care providers urging all users to immediately stop using the recalled products and remove them from their inventory.
Products Included in the Recall
Penumbra, Inc.’s recall affects at least 30,000 catheters and includes all configuration of the device:
- Penumbra JET 7 Xtra Flex catheter
- Penumbra JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device)
The recall does not include any Penumbra catheters with a standard tip.
How Does the JET 7 Xtra Flex Catheter Cause Injury?
The JET 7 Xtra Flex catheter is intended to restore blood flow by removing clots in stroke patients. However, the device seems to be susceptible to damage during use. When a JET 7 Xtra Flex catheter is pressurized or contrast material is injected into it, the device is prone to ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils.
As of December 15, 2020, at least 14 patients have died as a result of problems with the JET 7 Flex catheter. The FDA has received over 239 medical device reports unique reports of injury, death or other malfunction associated with the device.
These injuries include:
- Vessel Damage
- Hematoma or Hemorrhage at the site
- Cerebral Infarction
- Intracranial Hemorrhage
- Distal embolization
- Neurological deficits including stroke
According to the FDA safety alert, Penumbra Inc. is and has been aware of the issue. “Bench testing performed by the manufacturer, where the catheter distal tip is plugged and pressurized to failure, demonstrates that the 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.”
In July, 2020, the FDA prompted Penumbra to issue a warning against injecting contrast solution through the catheter along with additional warnings, precautions, and instructions to mitigate risks associated with the use of the device.
“Penumbra has received reports of Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) distal tip expansion or rupture when used during injection of contrast media. JET 7 Xtra Flex may become susceptible to expansion or rupture during contrast injection due to distal tip weakening from manipulation against resistance or use with other manufacturers’ revascularization devices.
Distal tip expansion or rupture may cause vessel damage and subsequent patient injury or death. Performing contrast injections through JET 7 Xtra Flex is not consistent with the intended use of the product or the Instructions for Use, which instructs the user to perform contrast injections through the guide catheter. ”
In many cases, healthcare providers continued to use contrast injection with the device, despite updated labeling and instructions. As a result, the FDA requested that Penumbra voluntarily recall them to protect patients.
If Penumbra Inc. was aware of the defect among their catheters, yet entered them into the market anyway, they are responsible for the injuries they cause. A JET 7 catheter lawsuit can hold them accountable for their actions and help secure justice for the patients and families who have been seriously injured or killed.
Do I Have a Case?
While the steps clinicians are directed to take after this recall are clear, affected patients may not have been afforded such clarity. Both the recall notice and the subsequent investigations are new, however. If you or a loved one were affected by a malfunctioning catheter, you may have a case if:
- You or a loved one had surgery after suffering an ischemic stroke after June, 2019 ( the device was cleared for use on June 16th, 2019)
- Any configuration of the Penumbra Jet 7 Xtra Flex catheter was used in that surgery to clear a blood clot
- You or your loved one suffered a serious injury – such as hematoma, hemorrhage, secondary stroke or death – during or as a result of that surgery
If you or your loved one suffered a serious complication during this time frame, but are unsure which catheter was used, please contact our JET 7 catheter lawsuit attorneys. We may be able to help you identify the cause of injuries and help hold Penumbra Inc. responsible for them. Call us today at (816) 268-1960 for a free and confidential case evaluation.