14 Deaths Caused by Penumbra JET 7 Catheters with Xtra Flex Technology
The FDA Sends an Urgent Warning Letter to Health Care Providers Warning of Increased Risk Serious Injury and Mortality with Penumbra’s JET 7 Catheters with Xtra Flex Technology.
Blood vessel damage
FDA – The U.S. Food and Drug Administration (FDA) is urgently notifying medical professionals about the critical Penumbra recall of all configurations of its Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) devices. The FDA’s letter warns of a risk of serious injury or unexpected death while these JET 7MAX and the JET 7 Xtra Flex catheter are used for removing blood clots in stroke patients. The FDA’s warning letter advises medical professionals to stop using the catheters immediately. The FDA’s urgent warning letter also recommends all medical facilities to remove the devices from their inventory following Penumbra’s Urgent Voluntary Medical Device Recall Notification. These Penumbra catheters and catheter kits are used to remove thrombus in patients who sustained an acute ischemic stroke.
On December 15, 2020, Penumbra began a voluntary recall of every JET 7 Xtra Flex configuration. However, the FDA is issuing a new urgent letter to all health care providers and medical facilities to make certain that all health care providers and medical facilities are apprised of this critical Class I recall.
The Penumbra catheters affected by the recall and this urgent FDA warning letter are:
- Penumbra’s JET 7 Xtra Flex Catheter (cleared under K190010 on June 16, 2019.)
- Penumbra’s JET 7MAX configuration, which includes the JET 7 Xtra Flex catheter and the MAX Delivery Device (which was cleared under K191946 on February 27, 2020.)
The recall does not pertain to Penumbra’s JET 7 Reperfusion Catheter with Standard Tip.
According to the FDA, the agency has reviewed more than 200 medical device reports (MDRs) connected with Penumbra’s JET 7 Xtra Flex catheter. The MDRs include dangerous adverse medical events such as malfunctions, serious injuries, and fatalities. There have been at least 14 deaths caused by the Penumbra JET 7 Xtra Flex catheters, as noted above. Additional MDRs report serious injuries to patients, including blood vessel damage, cerebral infarctions, hemorrhages, and brain hemorrhages.
The list of device failures provided in the medical device reports is expansion, ballooning, breakage, complete separation, rupture, and internal support coils exposure at the distal tip portion of the JET 7 Xtra Flex catheter.
Tragically, additional reports of device failures, injuries, and death continue to be received by the FDA. The FDA believes that some of the instructions were not performed by health care professionals. The FDA pledges to continue its efforts to keep the public notified of additional information is it becomes available. The FDA urges all affected by the recalled device to report the adverse event to Penumbra and to the FDA.
To report an adverse event to the FDA, simply click here and follow the FDA’s online directions. Immediate reporting of adverse medical issues helps the FDA identify and understand the dangers associated with defective medical devices on the market.
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