Use cautionMedical device recall · FDA · Published December 15, 2020
Penumbra JET 7 Kit: Distal Tip Damage Risk During Use
Penumbra recalls JET 7 Reperfusion Catheter kits due to potential distal tip damage during use that could cause vessel injury or death if contrast injection pressure is applied.
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.
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Contact the company
📍Recalling firmPenumbra Inc.1 Penumbra · Alameda, CA 94502-7610
✎ GovInfoNow plain-language explainer
Penumbra is recalling its JET 7 Reperfusion Catheter kits because the catheter tip may get damaged during use. This damage could cause vessel injury or death if contrast injection pressure is applied. Affected units were sold between specific lot numbers and dates. Read more at govinfonow.com/recall/63656-penumbra-jet-7-kit-distal-tip-damage-risk-during-use.
“Penumbra JET 7 Kit: Distal Tip Damage Risk During Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63656-penumbra-jet-7-kit-distal-tip-damage-risk-during-use. Based on FDA recall #Z-0849-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0849-2021%22&limit=1).
Penumbra Inc. recalled Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT due to potential vessel damage and patient injury or death, the FDA said on 2020-12-15.
Lot Number Range: C15441 thru C19176 F88882 thru F100278
The hazard
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.
Context
GovInfoNow's records show Penumbra Inc. has issued three other recalls since 2017-06-09, including the 2026-07-24 Penumbra RED 62 Reperfusion Catheter Recall for fracture risk and the 2026-06-03 Penumbra RED 68 Reperfusion Catheter Recall for fracture risk. Other recent recalls of similar products include the 2026-08-24 Boston Scientific Imager II Angiographic Catheters Recall for tip fracture risk and the 2026-06-15 Argon Medical L-Cath PICC Catheters Recall for leaking or cracking.
How to tell if you have this one
Check for the lot number range C15441 to C19176 and the F88882 to F100278 on the packaging. The product is sold under the catalog number 5MAXJET7KIT.
Brand
Penumbra
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Terminated
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.
Recall number
Product, codes & lots
Quantity
Z-0848-2021
Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 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.; Product Name: Penumbra JET 7 Reperfusion Catheter Catalog Number: 5MAXJET7 UDI Code: 00815948020955 Lot Number Range: C15558 thru C17703 F87621 thru F101011 H10851
3,368 catheters
Z-0849-2021
Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT 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.; Product Name: Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing Catalog Number: 5MAXJET7KIT UDI Code: 00815948020962 Lot Number Range: C15441 thru C19176 F88882 thru F100278
27,499 catheters
Z-0850-2021
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.; 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
0 catheters
Z-0851-2021
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.; 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
15 catheters
Based on the official FDA remedy
What to do — step by step
Check for Damage
Inspect the catheter tip for signs of damage before use.
Contact Manufacturer
Reach out to Penumbra Inc. for specific guidance on safe use or replacement options.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 47 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 3.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0849-2021 (December 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0849-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.