Last Updated March 4, 2021
The Penumbra Jet 7 Xtra Flex Catheter is a medical device that, until recently, was billed as part of a fully-integrated system for aiding with the removal of blood clots in patients suffering from acute ischemic stroke. Cleared for the U.S. market through the Food and Drug Administration’s (FDA) abbreviated 510(k) device clearance process, the Jet 7 Xtra Flex Catheter was designed to “vacuum” clots from arteries in the brain with minimally invasive procedures.
On December 15, 2020, Penumbra initiated a voluntary recall of the Jet 7 Xtra Flex Catheter after consultation with the FDA. The recall came on the heels of more than 200 medical device reports associated with the Jet 7 Xtra Flex which included deaths, serious injuries, and malfunctions. Further testing by Penumbra demonstrated that the device was not able to withstand previously assured operational pressures causing injuries and death.
What Is the Jet 7 Xtra Flex Catheter and How Does it Work?
The Jet 7 Xtra Flex is a “reperfusion” catheter which was coupled with specialized suction or “aspiration” devices manufactured by medical device company, Penumbra, Inc. Based in Alameda, California, Penumbra was established in 2004 to focus on devices tied to therapies that treat conditions such as stroke or aneurysm. The Jet 7 Xtra Flex was designed as a key component of a larger Penumbra Jet-Engine system which provides physicians with a complete package of tools for minimally invasive mechanical removal of cranial blood clots by vacuuming them out. This type of procedure is known as a thrombectomy and is a preferred method of extraction in acute ischemic stroke patients.
Traditionally, deep-vein thrombosis (DVT) and similar clotting conditions are approached with first-line drugs, known as lytics, which attempt to break down a clot over several hours or days. In recent years, lytic therapies have been combined with catheters to attempt to remove clots more effectively. Aspiration catheters such as the Jet 7 Xtra Flex, are maneuvered through the human vascular system through a small insertion in the groin. Once doctors approach the clot with the catheter, they use its suction to safely restore blood flow.
Aspiration catheters are touted as simple, low-cost options for removing small and relatively newer clots in a single session. However, larger and more cemented clots can overwhelm the suction potential of these devices and require additional follow-up procedures.
Are There Medical Issues and Side Effects Associated with the Jet 7 Extra Flex Catheter?
According to Penumbra, its Jet 7 Catheters have been associated with the following possible complications:
- Allergic Reactions with Contrasting Agents
- Acute Occlusion
- Air Embolism
- Arteriovenous Fistula
- Distal Embolization
- False Aneurysm Formation
- Hematoma or Hemorrhage at Access Site
- Infection
- Intracranial Hemorrhage
- Ischemia
- Kidney Damage from Contrast Agent
- Stroke
- Vessel Spasm
- Thrombosis
- Perforation
- Radiation Exposure Leading to Cataracts
- Skin Reddening
- Burns
- Alopecia
- Neoplasia from X-Ray Exposure
- Sudden Death
Why Is the Jet 7 Xtra Flex Being Recalled?
Penumbra announced an “urgent recall” of the Jet 7 Xtra Flex in December 2020 following consultation with the FDA. The recall advised that all medical providers should immediately cease using the Jet 7 Xtra Flex and remove them from inventory. Specifically, the devices cited in the recall are:
- Jet 7 Xtra Flex Catheter
- Jet 7Max Configuration
The recall does not apply to the Penumbra Jet 7 Repurfusion Catheter with Standard Tip.
The Jet 7 Xtra Catheter was approved for the U.S. market after review through the FDA’s abbreviated 510(k) device clearance process. However, post-market surveillance conducted by Penumbra and furnished to the FDA indicated a number of reports associating the Jet 7 Xtra Flex Catheter with deaths, serious injuries, and malfunctions at an alarming rate. Patient injuries described are as serious as vessel damage, hemorrhage, and cerebral infarction.
The FDA reported that Jet 7 Xtra Flex catheter failures included: ballooning; expansion; rupture; breakage or complete separation; and “exposure of internal support coils near the distal tip region of the [catheter]”. Internal post-market testing conducted by Penumbra indicated that the distal tip of the catheter is not able to withstand similar pressurization as Penumbra’s other catheters.
Are There Lawsuits Being Filed?
Following the recall announcement, attorneys for several stroke victims have begun thorough research into potential claims for injury resulting from the Jet 7 Xtra Flex Catheter.
Sources Cited (20)
1. “At FDA’s request, Penumbra recalls catheter device after 14 patient deaths” https://www.medtechdive.com/news/Penumbra-recalls-catheter-stroke-device-after-14-deaths/592338/
2. “Utilization of the large-bore Penumbra JET 7 reperfusion catheter in thrombectomy for acute ischemic stroke: A single-center experience” https://pubmed.ncbi.nlm.nih.gov/32693662/
3. “URGENT VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATIONIMMEDIATE ACTION REQUIRED” https://www.penumbrainc.com/wp-content/uploads/2020/12/JET-7XF-15Dec20.pdf
4. “JET 7 XTRA Flex reperfusion catheter related complications during endovascular thrombectomy” https://www.semanticscholar.org/paper/JET-7-XTRA-Flex-reperfusion-catheter-related-during-Majidi-Bageac/b564ae8beec12c7a473472b3aa535aad8ae6a316
5. “Urgent Recall for Penumbra JET 7 Xtra Flex Reperfusion Catheters” https://www.medscape.com/viewarticle/942732
6. “Penumbra Launches Jet 7 Reperfusion Catheter With Xtra Flex Technology in U.S.” https://www.dicardiology.com/product/penumbra-launches-jet-7-reperfusion-catheter-xtra-flex-technology-us
7. “Frontline Contact Aspiration Treatment for Emergent Large Vessel Occlusion: A Review Focused on Practical Techniques” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6372892/
8. “Direct thrombus retrieval using the reperfusion catheter of the penumbra system: forced-suction thrombectomy in acute ischemic stroke” https://pubmed.ncbi.nlm.nih.gov/21087940/
9. “Catheter-Based Clot Busting Therapies” https://www.dicardiology.com/article/catheter-based-clot-busting-therapies
10. “Penumbra Announces Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology Voluntary Recall” https://investors.penumbrainc.com/investors-relations/press-releases/press-release-details/2020/Penumbra-Announces-Penumbra-JET-7-Reperfusion-Catheter-with-Xtra-Flex-Technology-Voluntary-Recall/default.aspx
11. “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” https://www.fda.gov/medical-devices/letters-health-care-providers/penumbras-urgent-voluntary-recall-jet-7-catheters-xtra-flex-technology-due-increased-risk-mortality
12. “Penumbra JET® 7 Reperfusion Catheter with Standard Tip” https://www.penumbrainc.com/neuro-device/penumbra-jet-7/
Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.
