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JET 7 Xtra Flex Catheters Recalled After Injuries and Deaths

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Jet 7 Xtra Flex Catheter

Penumbra issued an urgent voluntary recall of all JET 7 Catheters with Xtra Flex Technology after reports of death and injuries, according to a Dec. 15, 2020, U.S. Food and Drug Administration notification.

“Penumbra is recalling the JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage during use,” according to Penumbra’s Urgent Voluntary Medical Device Recall Notification. “Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage, and subsequent patient injury or death.”

JET 7 Xtra Flex catheters are a part of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing. Medical providers use the system to remove blood clots in stroke patients and restore blood flow.

More than 30,000 units are affected by the recall. So far, Penumbra is aware of 17 patient injuries and 14 deaths caused by distal tip damage and expansion and rupture following contrast injection. There were also 11 patient injuries not related to distal tip damage.

The FDA recommends reporting all adverse events related to the Jet 7 Xtra Flex catheter to MedWatch and to stop using the device immediately.

Recalled Devices

The recall includes all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex). It does not include the Penumbra Jet 7 Reperfusion Catheter with Standard Tip.

Clinicians should stop using these medical devices, quarantine them from inventory and share the recall notification with their facility to ensure everyone is aware of the recall, according to Penumbra.

According to the FDA, the recalled JET 7 catheters 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.

Unique Device Identifier (UDI) numbers provided by Penumbra are: 00815948020962, 00815948021594 and 00815948020955.

Did you experience serious injuries from the JET 7 Xtra Flex catheter? Get a Free Case Review

JET 7 Xtra Flex Catheter Injuries

As of Dec. 15, 2020, Penumbra has filed 239 JET 7 Xtra Flex reports with the FDA for malfunction, injury, death and other events, the company said in its recall notification.
Reports of device failure include expansion, ballooning, breakage or complete separation, rupture and exposure of internal support coils near the distal tip region of the catheter.

Injuries linked to recalled devices include:

  • Death
  • Blood vessel damage
  • Cerebral infarction (stroke)
  • Hemorrhage

Warnings Prior to the Recall

After the FDA originally cleared the recalled devices in June 2019 and February 2020 through the 510(k) program, it continued to monitor postmarket safety and device performance. Before the recall, the agency had already observed problems with 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 agency said in its recall notification.

In its July 2020 notification to health care providers, Penumbra warned the “JET 7 Xtra Flex may become susceptible to expansion or rupture during contrast injection due to distal tip weakening from manipulation against resistance or use with other manufacturers’ revascularization devices.”

In August 2020, the FDA approved a new label warning against using contrast injection through the device.

In response to the recall, lawyers are accepting cases from stroke patients who suffered an injury or from individuals who lost a loved one after undergoing a procedure with the recalled devices.

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Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and women’s health issues. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • Member of American Medical Writers Association (AMWA) and former Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By

5 Cited Research Articles

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  1. Penumbra. (2020, December 15). Urgent Voluntary Medical Device Recall Notification. Retrieved from https://www.penumbrainc.com/wp-content/uploads/2020/12/JET-7XF-15Dec20.pdf
  2. 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
  3. U.S. Food and Drug Administration. (2019, June 16). 510(k) Premarket Notification, Penumbra System Reperfusion Catheter JET 7. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190010
  4. 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
  5. U.S. Food and Drug Administration. (2020, February 27). 510(k) Premarket Notification, Penumbra System Penumbra JET 7X. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191946
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