The US FDA has announced that Penumbra voluntarily recalled their JET 7 catheters. This recall is due to an increased risk of serious injuries and death in the patients using them. The device has been on the market since February 2020. Since Feb 2020, the FDA has received over 200 adverse medical device reports. These reports contributed to the urgent recall because they include adverse actions including reports of deaths, serious injuries, and device complications. According to the FDA’s notice, approximately 20 of the reported adverse actions include 14 patient deaths due to the device complications.
The voluntary recall states that all users should stop using the device and should get the device immediately removed by a medical professional. The recalled Penumbra devices include:
- The JET 7 Xtra Flex catheter, originally cleared under K190010 on June 16, 2019.
- The JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device) cleared under K191946 on February 27, 2020.
However, this recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.
If you have the recalled Penumbra devices in your inventory, Penumbra has provided the following information regarding the recalled inventory:
- Do not use the JET 7 Xtra Flex catheter
- Remove and quarantine all unused affected products in your inventory
- Return the affected products to Penumbra in accordance with Penumbra’s instructions
- Complete Penumbra’s product identification / return form
- Contact Penumbra Customer Service ([email protected] or 1.888.272.4606), available Monday – Friday 7:30 AM to 4:00 PM PST, with any questions or concerns
- Finally, report any adverse events or suspected events experienced with the JET 7 Xtra Flex through MedWatch, the FDA Safety Information and Adverse Event Reporting program
What is Penumbra JET 7 Xtra Flex?
The JET 7 Xtra Flex catheter is used by medical professionals to remove blood clots in individuals who suffered from a stroke. The device helps restore blood flow. The device acts as a semi-invasive “vacuum” inside the artery to ‘safely’ remove stroke-causing blood clots from the brain. Additionally, this device is a component of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing. The device was created to make removing blood clots simpler and safer, however, multiple adverse actions were reported to the FDA. Some of these injuries became serious enough to result in deaths.
Problems with Penumbra
As with all medical devices, there can sometimes be complications during insertion or removal. Some of the adverse reported actions (device complications) in this case are being reported are:
- Device Rupture
- Distal Tip Fracture
- Exposure of support coils
- Distal tip detachment
- Expansion of device
When a medical device like a catheter fails, it can result in many serious injuries such as:
- Blood Vessel Damage
- Cerebral Infraction
- Brain Bleed
- Ruptured Arteries
The Penumbra Lawsuit
When device recalls occur either voluntarily or forced, many times lawsuits will follow for individuals to recoup monies for the pain and suffering caused by the device. Many people are now filing lawsuits against Penumbra Inc. who are the manufacturers of the Jet 7 Stroke Catheter. Most clients will be suing for economic damages and non-economic damages such as:
- Medical bills
- Lost wages
- Mental health
- Chronic pain
- Emotional distress
Because we are in the early stages of the recall and the litigation, there is currently no state-issued MDL (Multi-district Litigation) currently.