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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 Technology see related information
Date Initiated by Firm December 15, 2020
Create Date January 18, 2021
Recall Status1 Open3, Classified
Recall Number Z-0851-2021
Recall Event ID 86989
510(K)Number K190010  K191946  K202251  
Product Classification Catheter, thrombus retriever - Product Code NRY
Product Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132

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: JET 7MAX (Penumbra JET 7 Xtra Flex + MAX Delivery Device) Catalog Number: J7XKIT132 UDI Code: 00815948021273  Lot Number Range: C21487 thru C21772 F97946 thru F98497
Recalling Firm/
Manufacturer		 Penumbra Inc.
1 Penumbra
Alameda CA 94502-7610
For Additional Information Contact Gita 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		 Under Investigation by firm
Action On 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 FDAs 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 Commerce 15 catheters
Distribution Worldwide 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 Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NRY and Original Applicant = Penumbra, Inc.
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