Penumbra Jet 7 Catheters Carry Risk of Serious Injury and Death, FDA Warns

Following more than 200 reports of problems with Penumbra Jet 7 Xtra Flex catheters, including at least 14 deaths, federal regulators have sent an urgent warning for healthcare providers to stop using the devices.

The manufacturer issued an urgent recall for all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (referred to as a “JET 7 Xtra Flex”), which are commonly used among stroke patients to remove blood clots.

In an FDA letter to healthcare providers sent on December 15, the agency indicated the catheters should no longer be used, and facilities should remove the devices from their inventories.

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The agency indicates it has received more than 200 medical device reports involving JET 7 Xtra Flex problems leading to serious injury or death. The data includes a total of 20 medical device reports describing at least 14 unique patient deaths. Problems mentioned in the reports include vessel damage, hemorrhage, and cerebral infarction that may have resulted from a malfunction or failure.

Device failures include ballooning, expansion, rupture, breakage, or complete separation and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex.

The FDA says it added the urgent letter to the recall notice to ensure health care providers were informed about the seriousness of the recall.

“Bench testing performed by the manufacturer, where the catheter distal tip is plugged and pressurized to failure, demonstrates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large bore aspiration catheters used to remove thrombus in acute ischemic stroke patients,” indicated the FDA recall alert.

Devices impacted by the recall include the JET 7 Xtra Flex catheter, originally approved by the FDA on June 16, 2019, and the JET 7MAX configuration, which includes the JET 7 Xtra Flex catheter and MAX Delivery Device) approved on February 27, 2020.

The recall does not apply to the Penumbra JET 7 Repercussion Catheter with Standard Tip.

The FDA calls for health care providers not to use the catheters, to remove and quarantine all unused products affected by the recall from their inventory, and to return the affected products to Penumbra in accordance with Penumbra’s instructions.

Affected customers can contact Penumbra Customer Service with any questions or concerns at 888-272-4606. Any side effects or suspected adverse events should be reported to the FDA’s MedWatch Adverse Event Reporting program.


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