Defective Penumbra Catheter Lawyers
Consult a product defect lawyer regarding your right to file a Penumbra catheter lawsuit if you or a loved one suffered serious injury or death while undergoing a blood clot removal procedure (thrombectomy) using a Penumbra Jet 7 Reperfusion Catheter. Due to a defect in the medical device, the Penumbra catheter may unexpectedly expand resulting in a leak or fracture of the tip. This can lead to hemorrhaging in the brain, loss of oxygen to the brain, blockage, and may necessitate extensive procedures to reclaim the lost tip. Call us to discuss your Penumbra catheter lawsuit today to learn your rights at (800) 298-0111.
Urgent Penumbra Catheter Recall Due to Defect
On December 15, 2020, an urgent voluntary recall was issued by Penumbra, Inc. for their Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology. The FDA has received over 200 reports of failures while using the catheters including 17 involving injury and another 14 that resulted in the death of the patient. Patients undergoing thrombectomy using these catheters may face a higher risk of serious injury or death due to the tip of the catheter expanding and/or breaking off inside the patient’s brain. Some reports suggest that Penumbra has known of this issue for some time.
What Penumbra Medical Devices Were Recalled?
The Penumbra Jet 7 Reperfusion Catheter recall includes the following devices:
- The JET 7 Xtra Flex catheter
- The JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device)
Physicians are instructed to cease using the devices and to remove them entirely from their product inventory. Report serious problems here.
This recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.
What is a Penumbra Jet 7 Reperfusion Catheter Used For?
The Penumbra Jet 7 Reperfusion Catheter is a device that is inserted through the groin and guided through the blood vessels up to the brain in order to suction out blood clots. They are intended to allow continuous aspiration in patients experiencing an acute ischemic stroke within 8 hours of symptom onset who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
What is the Penumbra Catheter Defect Reported to the FDA?
The reports to the FDA indicate that during thrombectomy, a number of issues may go wring with the Penumbra Jet 7 Reperfusion catheter, including the following:
- Ballooning and/or expansion of the device may result in blood vessel damage and/or rupture
- Device rupture
- Fracture of the distal tip
- Fraying and/or complete detachment of the distal tip
- Exposure of internal support coils
- Leakage.
What Injuries May Be Caused by a Defective Catheter?
Catheter failure can result in a number of serious injuries and even death due to resulting bleeding in the brain and/or blockage. Common injuries from a catheter failure in the brain include:
- Stroke
- Massive brain bleed
- Ruptured arteries
- Death.
Defective Penumbra Catheter Lawsuit Lawyer
Talk to a lawyer today regarding your right to bring a defective Penumbra catheter lawsuit if you suspect have been injured by a Penumbra catheter failure. Call Simmons and Fletcher, P.C. to get connected with an attorney investigating Penumbra catheter defect claims today if you or a loved one were informed that a Penumbra catheter failure during thrombectomy may have been the cause of serious injury. Call (800) 298-0111.