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According to the U.S. Food and Drug Administration (FDA), the medical device manufacturer Penumbra issued an urgent voluntary recall of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex). The recall was issued for all configurations, based on the risk of unexpected death or serious injury.

“The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.” (1)

More than 200 medical device reports were reported to the FDA. These reports included mentions of device malfunctions, causing serious injuries, and 14 patient deaths.

Injuries reported to the FDA amongst ischemic stroke patients included:

  • Vessel damage.
  • Hemorrhage.
  • Cerebral infarction.
  • Death.

W&L Accepting JET 7 Cases

Weitz & Luxenberg is now accepting cases from individual stroke patients who were injured, or whose loved ones died, after undergoing a blood clot removal procedure that used the recalled devices.

The recall instructed health care providers to “stop using this device, and facilities should remove these devices from inventory as directed in Penumbra’s Urgent Voluntary Medical Device Recall Notification.” (2)

Recalled Devices

Affected devices include all lot numbers of the Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing:

  • JET 7 Xtra Flex catheter, originally cleared under K190010 on June 16, 2019.
  • JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device) cleared under K191946 on February 27, 2020.

Included are these catalog and UDI numbers:

  • 5MAXJET7KIT, 00815948020962
  • 5MAXJET7L138KIT, 00815948021594
  • 5MAXJET7, 00815948020955

Device failure modes 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.” (3)

The manufacturer’s own testing “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.” (4)

JET 7 Indicated to Remove Blood Clots

The JET 7 Xtra Flex catheter and JET 7MAX configuration medical devices are “intended to restore blood flow by removing clots using continuous aspiration in patients experiencing an acute ischemic stroke.” (5)

They are a component of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing.

Voluntary Recall Issued

On December 15, 2020, manufacturer Penumbra issued a voluntary recall after numerous reports of the device not functioning as intended and patient injuries resulting.

Since initial clearance, the FDA continued to monitor the JET 7 Xtra Flex catheter and JET 7MAX configuration for performance and postmarket safety. In July 2020, manufacturer Penumbra was prompted by the FDA to issue a Notification to Healthcare Providers. It contained labeling mitigations, including additional warnings, precautions, and instructions to mitigate risks. (6)

The FDA cleared the updated labeling on August 31, 2020. It “included a warning against contrast injection through the device.” (7)

Because of received reports, as well as persistent risk, “the FDA requested that Penumbra voluntarily remove the JET 7 Xtra Flex from the market to protect patients.”(8)

W&L Helping Individuals Harmed by JET 7 Device

Ellen Relkin, chair of Weitz & Luxenberg’s Drug and Medical Device Litigation practice group says the firm is interested in hearing from you if you, or a loved one, experienced a negative reaction after a JET 7 catheter was used to treat a blood clot in your brain.

“We believe that having medical devices which function correctly is essential. When people are harmed by defective devices, the manufacturers should pay compensation for not only medical expenses, but also lost wages, and the pain and suffering caused by the failure,” Relkin states.

During her extensive career, Relkin has helped thousands of patients who were injured by defective medical devices. As part of the team, she helped secure a $1 billion settlement with Stryker due to defects in its Rejuvenate and ABGII modular hip implants. The medical device team at Weitz & Luxenberg includes an attorney who is also a medical engineer.

The attorneys at Weitz & Luxenberg are ready to assist you. Reach out to us for a free legal consultation. Use the online form or call us to discuss your legal options.

  1. U.S. Food and Drug Administration. (2021, January 29). Penumbra’s Recall of the JET 7 Reperfusion Catheter Due to Distal Tip Damage. Retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/penumbras-recall-jet-7-reperfusion-catheter-due-distal-tip-damage
  2. U.S. Food and Drug Administration. (2020, December 15). 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. Retrieved from https://www.fda.gov/medical-devices/letters-health-care-providers/penumbras-urgent-voluntary-recall-jet-7-catheters-xtra-flex-technology-due-increased-risk-mortality
  3. Ibid.
  4. Ibid.
  5. Ibid.
  6. Penumbra (2020, July 27). Notification to Healthcare Providers. Retrieved from https://www.penumbrainc.com/wp-content/uploads/2020/07/FINAL-Notification-to-Healthcare-Providers-27Jul20202.pdf
  7. U.S. Food and Drug Administration. (2020, December 15). 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. Retrieved from https://www.fda.gov/medical-devices/letters-health-care-providers/penumbras-urgent-voluntary-recall-jet-7-catheters-xtra-flex-technology-due-increased-risk-mortality
  8. Ibid.

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