The recall described in this notice is the same one that was announced in the Letter to Health Care Providers on December 15, 2020.
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.
- Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology, also known as JET 7 Xtra Flex
- All Lots
- Model or Catalog Numbers: The FDA’s Recall Classification Database
- Manufacturing Dates: May 10, 2019 – December 11, 2020
- Distribution Dates: June 17, 2019 - December 14, 2020; 30,882 devices distributed
- Devices Recalled in the U.S.: 22,656 devices.
- Date Initiated by Firm: December 15, 2020
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.
This recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.
Reason for Recall
On December 17, 2020, Penumbra recalled the Penumbra JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage during use. 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.
Who May be Affected
- Health care providers using this device during procedures for acute stroke.
- All patient groups undergoing procedures involving the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology.
What to Do
On December 15, 2020, Penumbra sent an Urgent Medical Device Recall notification to all affected customers with the following instructions:
- Share the recall notification with all users of the product within your facility to ensure that they are also aware of this recall.
- Immediately review your inventory for the specific catalog numbers listed in Penumbra’s Urgent Voluntary Recall Notice.
- Remove all units from inventory and place them in quarantine for return to Penumbra, Inc.
- Complete and return the product identification / return form provided by Penumbra within three business days.
- Continue to report adverse events and quality problems experienced with the use of this product. Adverse events and quality problems may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax. For more information, please see https://www.accessdata.fda.gov/scripts/medwatch/index.cfm.
Customers who have questions or concerns, please contact Penumbra Customer Service by phone at 1-888-272-4606, Monday - Friday between 7:30 am to 4:00 pm (Pacific Time), or by emailing firstname.lastname@example.org. Customers may also call their Penumbra Sales Representative.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.