FDA sends Urgent Letter to Health Care Providers
The U.S. FDA alerted healthcare providers in December 2020 that Penumbra issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex). The recall stemmed from the risk of the catheter causing unexpected death or serious injury while being used to remove clots in stroke patients. The FDA said all people should cease using these devices, and facilities should remove them from their inventory.
On December 15, 2020, Penumbra initiated a voluntary recall of all configurations of the JET 7 Xtra Flex from the market. The FDA issued its urgent letter to health care providers and facilities to inform them of the recall.
Penumbra issued its own Urgent Voluntary Medical Device Recall Notification as the FDA released its announcement. The affected devices include:
- The JET 7 Xtra Flex catheter, originally cleared under K190010 on June 16, 2019.
- The JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device) cleared under K191946 on February 27, 2020.
The Penumbra JET 7 Reperfusion Catheter with Standard Tip was not part of the recall.
200 Injury Reports, 14 Deaths
The FDA reported that it has received more than 200 medical device reports (MDRs) linked with the JET 7 Xtra Flex catheter. Those reports include deaths, serious injuries, and device malfunctions. Twenty of the 200 MDRs describe 14 unique patient deaths that include reports from different sources for a single adverse event.
Medical Device Reports describe serious patient injury, including:
- Vessel damage
- Cerebral infarction
- Complete separation
- Exposure of internal support coils
Penumbra’s bench testing showed that when JET 7 Xtra Flex catheter’s distal tip is plugged and pressurized to failure, it is unable to withstand the same burst pressures to failure as the device maker’s other large bore aspiration catheters. All are used to remove clots in acute ishemic stroke patients.
What is the Recalled Catheter Device?
The JET 7 Xtra Flex catheter and JET 7MAX configuration (JET 7 Xtra Flex catheter and MAX Delivery Device) are a component of the Penumbra System with aspiration pump and tubing. This device is designed to restore blood flow by removing clots with continuous aspiration in patients suffering acute ischemic stroke within 8 hours of symptom onset. It is indicated for use on those ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
The FDA said it has continued to monitor the postmarket safety and performance of the device, since allowing clearance (italics ours) of the JET 7 Xtra Flex catheter (K190010) and JET 7MAX configuration (K191946). The FDA prompted the device’s maker to issue a Notification to Healthcare ProvidersExternal Link Disclaimer on July 27, 2020. The agency demanded immediate labeling mitigations that included additional warnings, precautions, and instructions to mitigate risks associated with use of the device. The approved device with the updated labeling (K202251) was cleared via 510(k) by the FDA on August 31, 2020. The clearance included a warning against contrast injection through the device.
What is 510(k) Clearance? (It’s not FDA approval.)
The FDA’s 510(k) clearance allows some medical devices or treatments to reach the market without full and long-term safety testing, if the proposed new device is substantially equivalent to a device already on the market. As a result of this streamlined process, many devices “cleared” (as opposed to approved) via (510k), have later been recalled and subject to tort litigation. The enormous number of transvaginal mesh cases, nationwide, along with thousands of IVC blood clot filter lawsuits, are recent examples.
The FDA said that it continues to receive new MDRs related to the same Penumbra device’s failure modes. Some reports, it added, dispute whether the updated instructions were followed by health care providers. Because of the persistent risk, the FDA asked Penumbra to voluntarily remove the JET 7 Xtra Flex from the market.
Penumbra hence issued an Urgent Voluntary Medical Device Recall Notification notifying users of the removal of all configurations of the JET 7 Xtra Flex from the market.
The FDA continues to work with Penumbra on the voluntary recall. The agency further said that patients who have been successfully treated with the device are not affected by the recall.
As with the new Covid “vaccines,” the FDA encourages people to report all adverse events to the manufacturer and the FDA.