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This month, the FDA announced an urgent recall of JET 7 reperfusion catheters with Xtra Flex Technology following suspicion that the tip of the catheters were causing serious damages and death to patients. The device was reported to have caused “ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the Jet 7 Flex catheter.” Included in the recall were two specific types of Jet 7 catheters:the JET 7 Xtra Flex catheter and the JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device).

We typically think that catheters are used in the bladder to help regulate urine. However, a catheter is actually a broad term to describe medical devices that are designed to enter the body to treat a disease or perform a surgical procedure. The Jet 7 catheters are designed to restore blood flow by removing blood clots by aspiration (suction) in patients who experience acute ischemic strokes. This device is selectively used within 8 hours of stroke symptoms, before patients are eligible for other treatments.

The recall was announced after 200+ medical device reports (MDRs) associated with the Jet 7 Xtra Flex Catheters were found to include deaths, serious injuries, and significant malfunctions. In addition, the MDRs described patient injuries that included vessel damage, hemorrhage, and cerebral infarction as well as device failures that included rupture, breakage or complete separation, and exposure of internal support coils.

Bench testing of the devices, done by Penumbra, found that the catheter’s distal tip is not able to withstand the same burst pressures as the manufacturer’s similar aspiration catheters used for the same acute ischemic stroke patients. When “pressurized to failure” the catheter was found to be significantly less resilient than other similar models that doctors use regularly.

Penumbra’s CEO, Adam Elsesser, has been clear in his comments that the health of patients is their priority. "If we can't mitigate the risk, then this is the right exit," Elsesser added. All the while, Elsesser maintained that the products were highly effective and “would have been on the market for many years” if risks could have been mitigated.  

Unfortunately, those risks were not mitigated, and the device was being used for almost an entire year before it was recalled. With the recall only weeks behind us, it is still uncertain how many more patients have been injured by the device. We will make sure to keep you updated on any legal updates to the recall as the case develops.  

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