Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspirati...
FDA Recall #Z-0851-2021 — Class I — December 15, 2020
Product Description
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.
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.
Recalling Firm
Penumbra Inc. — Alameda, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
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.
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated