MIL-OSI USA: Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers

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Source: US Food and Drug Administration

The U.S. Food and Drug Administration (FDA) is alerting you that Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious injury while used for removing clots in stroke patients. All users should stop using this device, and facilities should remove these devices from inventory as directed in Penumbra’s Urgent Voluntary Medical Device Recall Notification.

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.

This recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.

The FDA has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunctions. Twenty of these MDRs describe 14 unique patient deaths, which include reports from different reporting sources for a single adverse event. Other MDRs describe serious patient injury such as vessel damage, hemorrhage, and cerebral infarction. Device failure modes reported in the MDRs 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 catheter.

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.

On December 15, 2020, the manufacturer (Penumbra) initiated a voluntary recall of all configurations of the JET 7 Xtra Flex from the market. The FDA is issuing this urgent letter to health care providers to ensure that health care providers and facilities are informed of this important recall.

FDA Recommendations:

  • Follow all instructions provided in Penumbra’s Urgent Voluntary Medical Device Recall Notification:
    • Do not use the JET 7 Xtra Flex catheter
    • Remove and quarantine all unused affected products in your inventory.
    • Return the affected products to Penumbra in accordance with Penumbra’s instructions.
    • Complete Penumbra’s product identification / return form
    • Contact Penumbra Customer Service (order@penumbrainc.com or 1.888.272.4606), available Monday – Friday 7:30 AM to 4:00 PM PST, with any questions or concerns.
  • Report any adverse events or suspected events experienced with the JET 7 Xtra Flex through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Background

As a component of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing, the JET 7 Xtra Flex catheter and JET 7MAX configuration (JET 7 Xtra Flex catheter and MAX Delivery Device) are medical devices intended to restore blood flow by removing clots using continuous aspiration in patients experiencing an acute ischemic stroke within 8 hours of symptom onset who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

FDA Actions

Following clearance of the JET 7 Xtra Flex catheter (K190010) and JET 7MAX configuration (K191946), the FDA has continued to monitor the postmarket safety and performance of the device. The FDA prompted the manufacturer to issue a Notification to Healthcare Providers on July 27, 2020, with immediate labeling mitigations that included additional warnings, precautions, and instructions to mitigate risks associated with use of the device by health care providers. The 510(k) with the updated labeling (K202251) was cleared by the FDA on August 31, 2020 and included a warning against contrast injection through the device.

Since Penumbra’s labeling update and Notification to Healthcare Providers, the FDA continues to receive new MDRs related to the same device failure modes, including some reports where the updated instructions were not followed by health care providers. Because of the persistent risk, the FDA requested that Penumbra voluntarily remove the JET 7 Xtra Flex from the market to protect patients. Penumbra has 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 the manufacturer on the voluntary recall. Patients who have been successfully treated with the device are not affected by this voluntary recall.

The FDA will continue to keep the public informed if new or additional information becomes available. The FDA encourages you to report all adverse events to the manufacturer and the FDA.

Reporting Problems to the FDA

Report all adverse events or suspected adverse events related to the JET 7 Xtra Flex and JET 7MAX that come to your attention.

  • Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
  • Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
  • Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
  • When possible, reports should include the following information: 
    • Anatomical location, vessel size, time from symptom onset, and concomitant treatments of the vessel occlusion. 
    • Vessel anatomical characteristics (tortuosity).
    • Whether the adverse event occurred intra-procedurally or post-procedurally.
    • A complete description of the adverse event and patient outcome, if available.
    • The device model names and numbers.
    • Any ancillary devices used during the procedure, such as the specific trade name and size of the microcatheter, intermediate catheter, guide catheter, guidewire and stent-retriever, if applicable.
    • Any ancillary fluids or drugs used during the procedure, such as contrast agents and saline flushes, if applicable, and the delivery device used.
    • Unique device identifier (UDI).

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).

  • Email: DICE@fda.hhs.gov
  • Phone: 1(800) 638-2041 or (301) 796-7100

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