Today, the U.S. Food and Drug Administration (FDA) issued an Urgent Letter to Health Care Providers about Penumbra JET 7 Reperfusion Catheters with XTRA FLEX Technology. The letter advises users to stop using the device as directed in Penumbra’s Urgent Voluntary Medical Device Recall Notification because of the increased risk of mortality and serious injury associated with its use in stroke patients. All users should stop using this device, and facilities should remove this device from inventory as directed in Penumbra’s Urgent Voluntary Medical Device Recall Notification.
The FDA has received over 200 medical device reports (MDRs) associated with the JET 7 XTRA FLEX including malfunctions, serious injuries, and 14 patient deaths associated with use of the device.
If Penumbra JET 7 Reperfusion Catheters with XTRA FLEX Technology were responsible for your injury or the death of a loved one, you may legally deserve compensation for your losses, which could include:
We know how expensive, emotionally damaging, and physically traumatic injuries like these can be can be. We also know that medical device companies must be held responsible for their errors in order to create a safer and more just world. We want to stand up with you against these negligent businesses to make certain that these mistakes don’t harm future patients.
It can be difficult to know if post-surgery complications were caused by a defective medical device, such as a catheter. The best way to learn more about your case is to speak with an experienced defective medical device attorney about the details of your case.
At Sweeney Merrigan Personal Injury Lawyers, we are dedicated to helping those harmed by negligent medical device companies. One of the ways we show our dedication is by offering those affected by Penumbra JET 7 Reperfusion Catheters a free, private consultation with one of our attorneys. To schedule your meeting, please contact us today via contact form or call (617) 362-4713.