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U.S. Department of Health and Human Services

Class 1 Device Recall Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology

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 Class 1 Device Recall Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technologysee related information
Date Initiated by FirmDecember 15, 2020
Date PostedJanuary 18, 2021
Recall Status1 Terminated 3 on May 14, 2024
Recall NumberZ-0850-2021
Recall Event ID 86989
510(K)NumberK190010 K191946 K202251 
Product Classification Catheter, thrombus retriever - Product Code NRY
ProductPenumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
Code Information Product Name: Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing Catalog Number: 5MAXJET7L138KIT UDI Code: 00815948021594  Lot Number Range: F97123 thru F98981 Note - none were distributed
Recalling Firm/
Manufacturer		 Penumbra Inc.
1 Penumbra
Alameda CA 94502-7610
For Additional Information ContactGita Barry
510-748-3200
Manufacturer Reason
for Recall		The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
FDA Determined
Cause 2		Process design
ActionOn 12/15/2020, the firm posted a press release (https://www.penumbrainc.com/wp-content/uploads/2020/12/JET-7XF-15Dec20.pdf) and issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter via FedEx informing customers that all configurations of their reperfusion catheters may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage, and subsequent patient injury or death. Customers are instructed to: 1. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 2. Immediately review your inventory for the specific catalog numbers listed above. 3. Remove all units from inventory and place them in quarantine for return to Penumbra, Inc. 4. Complete and return the attached product identification / return form within 3 business days. 5. Continue to report adverse events and quality problems experienced with the use of this product. Adverse events and quality problems may be reported to 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. The Recalling Firm will contact customers directly to arrange return of affected units and replace/refund returned product. If customers have any questions or concerns, they can contact the Recalling Firm's Customer Service (order@penumbrainc.com or 1.888.272.4606), available Monday - Friday 7:30 AM to 4:00 PM PST, or their sales representative.
Quantity in Commerce0 catheters
DistributionWorldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NRY
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