Penumbra Inc. has issued an urgent voluntary recall of the all configurations of Penumbra JET 7 Xtra Flex Catheters on December 17 , 2020 used in cases of ischemic stroke patients to remove thrombus. The FDA has received more than 200 failure reports associated with these catheters. Out of the 200 reports , 14 included patient deaths, 17 injuries like vessel damage , hemorrhage and cerebral infarction and other device malfunctions have been reported.
Patients are at a high risk of injuries or death due to the distal tip of catheter expanding, rupturing or breaking inside the patient's brain while undergoing the thrombectomy. As per the bench testing by the manufacturers of the catheter , it was observed that the distal tip of the catheter is unable to withstand the same burst pressures to failure as their other large bore aspiration catheters.
Considering the safety concerns of the device , FDA on 27 July 2020, suggested the manufacturer to issue a notification to the health care providers labelling warnings , precautions and information to mitigate risks.
Patients who have been already been treated successfully with the device will not be affected by this recall.
Penumbra JET 7 Xtra Flex Catheters was introduced to the market in July 2019 in an elaborate event for patients with acute ischemic stroke secondary to large vessel occlusion. These caterers are the next generation reperfusion catheters for usage in thrombectomy surgeries, designed for advanced navigation to extract clot with power of Penumbra Engine aspiration source.
These catheters with Xtra Flex technology together with the power of the Penumbra Engine allows physicians to remove clots in stroke patients with minimal invasion.
Penumbra Inc. based out of Alameda, California are the manufacturing leaders of the neurovascular devices. Penumbra received their first U.S. Food and Drug Administration (FDA) approval in 2007 that allowed marketing of the aspiration catheter for treatment of patients who had suffered strokes. Following the success of these first pioneered aspiration catheters, Penumbra did multiple clinical studies and introduced several revolutionary devices for suction thrombectomy.
From its launch in 2007 to 2018, around 80% of all the suction thrombectomies performed for stroke patients in the United States were with the assistance of Penumbra aspiration catheters. In 2018 , some of the bigger players introduced various versions of aspiration catheters, but Penumbra leads the market. It is the preferred assistant in most surgeries with 65% of around 50,000 suction thrombectomies undergone in the US.
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