In December 2020, device manufacturer Penumbra recalled over 22,000 Penumbra JET 7 Xtra Flex catheters and JET MAX delivery devices which include the JET 7 Xtra Flex catheters. The JET 7 catheters are medical devices used to restore blood flow by removing clots in patients experiencing ischemic strokes.
They are intended to be used within 8 hours of symptom onset in patients who are ineligible for intravenous tissue plasminogen (IV t-PA) or in patients whose TPA did not work. The recall did not apply to the Penumbra JET 7 reperfusion catheter with standard tip.
The recall was issued in December 2020 because the catheter tip may become damaged at the tip during use. This may result in serious injury, malfunction, and death.
JET 7 Catheter Recall Details
In December, Penumbra sent an Urgent Medical Device Recall Notification to all affected customers with instructions to inventory, quarantine and return involved catheters to Penumbra. January 29, 2021, the FDA announced that the recall had been classified as “Class I” indicating the most serious type of recall performed because use of the device may lead to serious injury or death.
All lots, all model numbers of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology, also known as JET 7 Xtra Flex and the JET MAX delivery device which includes one of the catheters. The affected catheters were made between May 10, 2019 and December 11, 2020.
At least 14 deaths have been associated with the catheter’s use. Other patients experienced serious injury including vessel damage, hemorrhage, and stroke and at least 239 medical device reports have been filed with the FDA.
Device failures have included ballooning, expansion, rupture, breakage, separation, and exposure of internal coils near the distal tip region of the JET 7 Xtra Flex catheter.
What is Penumbra JET 7 Reperfusion Catheter?
The Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology is an aspiration catheter designed to treat people who have had a stroke. It is intended to remove clots during an aspiration thrombectomy procedure, using suction applied through the catheter.
An aspiration catheter is a thin tube that is inserted through an incision at the groin or wrist. The catheter is then guided to a brain clot and suction is used to remove the clot so that blood flow can be restored. Aspiration thrombectomies are performed about 50,000 times per year.
Between 2007 and 2018, about 80 percent of suction thrombectomies performed in the U.S. used a Penumbra catheter and even though larger medical device companies like Stryker and Medtronic are now selling aspiration catheters, Penumbra still dominates the market. The JET 7 Xtra Flex catheter is reportedly responsible for about 30 percent of the company’s sales.
14 deaths associated with use of the catheters in just about 18 months. Reports indicate that the device’s distal (farthest) tip suddenly expanded or fractured and may have resulted in arterial rupture, often in the carotid artery which supplies blood to the brain and eyes.
What is the Penumbra JET 7 Catheter Used For?
Penumbra JET 7 Xtra Flex catheter and JET 7 MAX configuration (MAX Delivery Device) are used to restore blood flow by removing blood clots within 8 hours of symptom onset in patients who are ineligible for IV tissue plasminogen activator or those who failed IV t-PA therapy.
Acute Ischemic Stroke is a loss of blood flow to a certain area of the brain which may result in tissue death. It can be caused by a blood clot which has formed or lodged in an artery to occlude or block blood flow and cut off the oxygen supply to brain tissue.
Acute ischemic stroke due to blood clot formation is often treated by infusion of tissue plasminogen activator (t-PA), a medication intended to break down the clot and restore blood flow to the affected area. Restoration of blood flow is known as “reperfusion”.
Unfortunately, not all patients may be eligible for t-PA infusion or in some cases, t-PA may not have worked. Aspiration catheter procedures may be used in these cases, if the procedure can be conducted within 8 hours of symptom onset.
Penumbra JET 7 Catheter Lawsuits
At least 14 deaths and multiple injuries have already been associated with the Penumbra JET 7 Xtra Flex catheter. This also includes over 200 medical device event reports which indicated deaths, injuries and other malfunctions.
Problems with the catheter included ballooning, expansion, fracture or breakage of the catheter tip which may have caused:
- Vessel damage
- Arterial rupture
- Hemorrhage
- Cerebral Infarction
- Death
If you or a loved one underwent aspiration thrombectomy or blood clot surgery between July 2019 and December 2020 and were injured or experienced complications, you may be eligible for compensation and should seek legal advice.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
Sources
- Penumbra’s Recall of the JET 7 Reperfusion Catheter Due to Distal Tip Damage, U.S. Food and Drug Administration (01/29/2021)
- Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers, U.S. Food and Drug Administration (12/15/2020)
- Penumbra System, Mechanical Thrombectomy, Penumbra Inc. (02/2021)