Blood clot surgery complications may be due to faulty Penumbra JET 7 Reperfusion Catheter
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). Injured patients and their families 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 FDA has identified this as a Class 1 recall, the most serious type of recall, indicating that use may cause serious injuries or even death.
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 (including the company’s aspiration pump and tubing), that aim to restore blood flow in patients who have recently experienced an acute stroke. The devices are meant to remove clots by using continuous aspiration. It is used for 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, the “Penumbra System,” which maker Penumbra designed to perform mechanical thrombectomies. A procedure to remove a clot from a patient’s artery with specialized equipment, a mechanical thrombectomy is used most often to treat an ischemic stroke, which is 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.
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:
- 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.
Injured patients and their families may sue for damages
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
- Cerebral infarction
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.
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