The Food and Drug Administration (FDA) has recently recalled all the configurations of the Penumbra JET 7 Xtra Flex due to the heightened risk of death or serious injury. The FDA has recommended that people should immediately stop using these devices and that medical facilities should remove them from their inventory.
The Penumbra JET 7 Xtra Flex catheter was designed to remove blood clots and restore blood flow in patients who suffered a stroke. While this device was designed with good intentions the FDA received over 200 medical device reports stating the different injuries patients incurred when the device was in use. Injuries have included:
- Cerebral hemorrhages
- Device malfunctions
- Other serious injuries such as cerebral infection
Unfortunately, many of the reports the FDA received claimed the device failed. There were a few different modes of failure for this device such as device expansion, ballooning, separation, or device rupture. When the device failed patients sustained serious injuries as a result.
Penumbra Issuing Voluntary Recall
On December 15, 2020 Penumbra issued an urgent voluntary medical device recall for the JET 7 Xtra Flex Catheter admitting that the device has caused some injuries. Penumbra claims that of the 30,000 distributed units there were 17 patient injury events, 14 patient deaths, and that Penumbra has filed 239 reports for circumstances that led to death, injury, or malfunctions due to the JET 7 Xtra Flex. Penumbra has also told facilities that have the recalled devices in their inventory that someone will reach out to them about replacing or returning the device.
Contact Us Today
If you or a loved one were injured from the use of the Penumbra JET 7 Xtra Flex device, or lost someone, contact the Whitley Law Firm today. It is important to speak to a lawyer sooner rather than later to see if you could have a claim against Penumbra. Our lawyers are experienced in the product liability field and could help guide you through the complex legal process. The Whitley Law Firm is on your side and wants to help you obtain compensation for your loss or injuries.