Penumbra Inc.: 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.

Recall number

Z-0850-2021

Recalling firm

Penumbra Inc.

Product

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.

Status

Terminated

Initiated

2020-12-15

Posted

2021-01-18

Terminated

2024-05-14

Reason

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.

Root cause

Process design

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 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

0 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.

Lot, serial or model codes

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

510(k) numbers

["K190010","K191946","K202251"]

PMA numbers

not on file

Product code

NRY

Firm FEI

3005168196

Firm city

Penumbra Alameda

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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