On December 15, 2020, Penumbra, a manufacturer of neuro and vascular medical devices initiated an urgent voluntary recall that was recommended by the FDA to remove all configurations of the JET 7 Reperfusion Catheters from hospitals and health care facilities. These devices have malfunctioned causing serious injuries, including death.
- The affected devices include:
- – The JET 7 Xtra Flex catheter, originally approved by the FDA on June 16, 2019.
- – The JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device) was approved by the FDA on February 27, 2020.
The Penumbra System is designed to remove blood clots in the brain of stroke patients. A minimally invasive surgery is performed using a catheter intended to capture and remove blood clots. Tragically, a defect in the JET 7 Flex Catheter caused serious injuries and even death in some patients.
- Injuries caused by Penumbra’s JET 7 products:
- – Vessel Damage
- – Hemorrhage
- – Cerebral Infarction
- – Death
According to the FDA ‘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.’
- The defective devices have failed as follows:
- – Ballooning
- – Expansion
- – Rupture
- – Breakage or Complete Separation
- – Exposure of internal support coils
At The Nations Law Firm we have years of experience in pharmaceutical and medical device litigation. It’s what we do. We have the resources, knowledge, and commitment required to stand up to the drug and device companies and fight for your rights. If you or someone you know has suffered from vessel damage or other serious injury after undergoing brain surgery where a Penumbra catheter was used, please contact our offices for a free case evaluation with one of our attorneys. Our toll-free number is 1-800-269-3050.