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Penumbra JET 7 Catheter Lawsuits

The Food and Drug Administration (FDA) has issued an alert concerning Penumbra’s recall of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) due to the risks of death or serious injury. The device is used to eliminate clots in patients who have had a stroke. The FDA warned that patients and facilities should discontinue using the Penumbra JET 7 Catheter immediately.

Penumbra JET 7 Catheter Lawyers are Ready to Help

Contact our Penumbra JET 7 Catheter Lawyers to review whether you or a family member may be entitled to financial compensation. Levy Konigsberg LLP is currently accepting Penumbra JET 7 Catheter cases in all 50 states.

If you or a loved one has suffered one or more of these complications, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation with Penumbra JET 7 Catheter Lawyers at our law firm, please call (800) 315-3806or submit an email inquiry.

What is Penumbra JET 7 Catheter?

Penumbra JET 7 Xtra Flex Catheter is a popular aspiration catheter that is used to remove blood clots in thrombectomies (a surgical procedure in which blood clots are removed from arteries and veins). The catheter is a thin tube that is inserted into the patient and guided toward an arterial clot in the brain. Then suction is applied to remove the clot and restore normal blood flow in stroke patients. Penumbra first received approval for its aspiration catheter in 2007. Since then, Penumbra has marketed several configurations of the Penumbra catheter. Between 2007 and 2018, 80% of the suction thrombectomies procedures in the United States used Penumbra catheters.

What is Happening with Penumbra JET 7 Catheters?

In December 2020, the FDA alerted the public about Penumbra’s Urgent Voluntary Medical Device Recall Notification. The Notification concerns the JET 7 Xtra Flex catheter and the JET 7MAX configuration (including the JET 7 Xtra Flex catheter and MAX Delivery Device).

Over 200 medical device reports related to failure of the JET 7 Xtra Flex catheter were submitted to the FDA. According to the reports, adverse conditions including death and severe injuries have resulted from using the device. Twenty of these cases reported 14 unique patient deaths related to the Penumbra JET 7 Catheter. Other reports describe injuries, such as vessel damage and hemorrhage. The injuries associated with device failure are caused by ballooning, rupture, or separation of the catheter’s distal tip.

The manufacturer had previously issued a Notification to Healthcare Providers in July 2020 at the request of the FDA. The Notification called for new label warnings and precautions in light of the risks presented by the JET 7 Xtra Flex Catheter. Since that time, Penumbra continued to receive reports of device failure, which led the FDA to urge Penumbra’s voluntary recall of the Jet 7 Xtra Flex Catheter from the market.

https://www.fda.gov/medical-devices/letters-health-care-providers/penumbras-urgent-voluntary-recall-jet-7-catheters-xtra-flex-technology-due-increased-risk-mortality

https://www.penumbrainc.com/wp-content/uploads/2020/07/FINAL-Notification-to-Healthcare-Providers-27Jul20202.pdf

Penumbra JET 7 Catheter Side Effects and Complications

Complications of Penumbra JET 7 Catheter include:

Vessel damage;
Hemorrhage;
Cerebral infarction; and
Death.

Penumbra JET 7 Catheter Lawyers are Ready to Help

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