Home / Recalls / Penumbra Inc. / Z-0850-2021

Z-0850-2021 Class I Terminated

Recalled by Penumbra Inc. — Alameda, CA

FDA device recall Z-0850-2021 was initiated by Penumbra Inc. on December 15, 2020 and is designated Class I. 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 p… The recall status is terminated (terminated May 14, 2024). Affected quantity: 0 catheters.

Recall Details

Product Type: Devices
Report Date: January 27, 2021
Initiation Date: December 15, 2020
Termination Date: May 14, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 0 catheters

Product Description

Penumbra 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.

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.

Distribution Pattern

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: 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

Other recalls by Penumbra Inc.

Z-0849-2021 Class I — Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5 (December 15, 2020)
Z-0851-2021 Class I — Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + (December 15, 2020)
Z-0848-2021 Class I — Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusi (December 15, 2020)
Z-2702-2017 Class I — Penumbra 3D Revascularization Device It is indicated for used in the revascular (June 9, 2017)