Penumbra Catheter Lawsuit
Patients who underwent blood clot surgery between July 2019 and December 2020 and who experienced complications may have been injured by a faulty surgical catheter, the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex). This device was recalled in December 2020.
People or loved ones of those injured by the Penumbra JET 7 Xtra Flex Catheter or JET7MAX Delivery Device may be eligible for compensation.
FDA Recalls Penumbra Catheter Device After 14 Patient Deaths
The Food and Drug Administration (FDA) directed medical device maker Penumbra to recall all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) in December 2020 after receiving over 200 reports of serious issues with the device, including severe injury, malfunctions, and death. The December 2020 recall affected over 30,000 catheter units.
The FDA received hundreds of medieval device reports indicating a wide variety of injuries caused by the faulty Jet 7 Xtra Flex catheter, including:
- Vessel damage
- Hemorrhage
- Cerebral infarction
- Death
Yet despite the many deaths reported since the Penumbra Jet Xtra Flex catheter appeared on the market, device maker Penumbra only warned healthcare providers of potential complications in July 2020. Patients who underwent blood clot surgery between July 2019 and December 2020 and who experienced complications may sue Penumbra for damages.
Penumbra JET 7 Catheter Used in Clot Removal Surgery
Introduced in July 2019, the JET 7 Xtra Flex catheter and JET 7MAX configuration (JET 7 Xtra Flex catheter and MAX Delivery Device) are components of the “Penumbra System,” a branded group of medical devices (include the company’s aspiration pump and tubing), that intend to restore blood flow in patients who have recently experienced an acute stroke.
The devices aim to remove clots by using continuous aspiration. It is used in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
Faulty Medical Device Wreaks Havoc in Vulnerable Patients
Penumbra’s Jet 7 Xtra Flex catheter is part of a suite of devices Penumbra designed to perform mechanical thrombectomies. Mechanical thrombectomy is a procedure to remove a clot from a patient’s artery with specialized equipment. This procedure is used most often to treat ischemic strokes, which are caused by a blood clot that forms in an artery leading to the brain, or which is swept into a brain artery from elsewhere in the body. Slowing or stopping blood supply to the brain, these clots can cause permanent brain damage in minutes. Quick, safe removal of the clot is essential to recovery.
Injuries Caused by Penumbra JET 7 Catheter
Several hundred medical device reports submitted to the FDA detailed serious patient injury caused by Penumbra’s faulty Jet 7 Xtra Flex catheter and Jet 7Max configuration.
Injuries were called by multiple types of device failure, including:
- Ballooning
- Expansion
- Rupture
- Breakage
- Complete separation
- Exposure of internal support coils
Further testing demonstrated that the JET 7 Xtra Flex catheter is not able to withstand adequate pressure. Penumbra initiated a recall on December 15, 2020, after a request by the FDA.
Penumbra JET 7 Xtra Flex Catheter Lawsuits
The FDA has received at least 200 reports of serious injury including at least 14 deaths linked to the Penumbra Jet Xtra Flex. Device maker Penumbra may have known about the dangers of the catheter but did not warn healthcare providers of potential complications until July 2020.
This may have left numerous stroke victims at risk of additional injury including:
- Vessel damage
- Hemorrhage
- Cerebral infarction
- Death
Penumbra may be facing numerous lawsuits filed for injury due to a blood clot removal surgery performed with a Penumbra JET 7 catheter. The company has been accused of manufacturing a dangerous product and of knowing the product was dangerous, failing to warn the public and medical professionals and selling it anyway.
Patients who underwent clot removal surgery with a Penumbra JET 7 Xtra Flex Catheter or JET 7MAX Delivery Device after having a stroke may have been placed at additional risk of serious injury. People and loved ones of those who were injured by the Penumbra JET 7 catheter procedure may be eligible for compensation.