The U.S. Food and Drug Administration has issued a Class 1 recall for Penumbra’s JET 7 Reperfusion Catheter because the tip of the device could become damaged and potentially cause severe injury or death. According to an alert posted on the FDA’s website, Penumbra warned doctors to stop using these stroke catheters back on Dec. 15 after 14 patients died of major brain bleeding.
The FDA has also said it has received more than 200 reports of adverse events including serious injuries, deaths and malfunctions. These injuries include vessel damage, hemorrhage and stroke. A stroke is essentially a brain lesion in which a cluster of brain cells die when they don’t get a sufficient supply of blood.
Details of the Recall
The problem with these products is that the tip of the catheter could potentially break off and expand like a balloon inside the patient’s brain causing catastrophic brain bleeding and death. JET 7 catheters are typically used in patients who are experiencing a stroke, according to the FDA. The federal regulator’s alert says these medical devices are intended to restore blood flow by removing clots using continuous aspiration in patients who are experiencing an acute ischemic stroke within eight hours of symptom onset.
The recall involves about 30,882 devices worldwide that were distributed between June 17, 2019, and Dec. 14, 2020. FDA’s Class 1 recalls are issued for medical devices with the most serious safety issues. This recall comes after the JET 7 was called a “killer catheter” by Quintessential Capital Management (QCM) and following criticism that the product was rushed to the market. QCM had warned in its November report that the increased flexibility offered by the catheters may have made it more prone to malfunctioning.
Product Liability Issues
There is no question that this particular medical device has failed or malfunctioned resulting in catastrophic injuries or deaths. Medical device manufacturers, like all product manufacturers, have a responsibility to make products that are safe for consumers. This is particularly significant for medical devices because they are used in life-and-death situations. Many medical devices are implanted in patients, which means when these devices malfunction, patients need costly and painful surgeries to remedy the situation.
In such cases where medical devices fail and cause injuries, victims can file a product liability lawsuit seeking compensation for damages such as medical expenses, lost income, hospitalization, permanent injuries, disabilities and pain and suffering. A family that has lost a loved one to a defective medical device can file a wrongful death lawsuit against the manufacturer seeking compensation as well. An experienced product defect lawyer will be able to advise injured victims and their families regarding their legal rights and options.