Summary
The FDA issued a Class II for Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT by Penumbra, Inc.. Reason: Due to manufacturing issues, reperfusion catheters may fractures.
Details
Source
Device Recall
External ID
Z-2770-2026
Action Date
2026-07-29
Status
Ongoing
Category
device
Product Description
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Lot/Code Info: UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
Quantity Affected: N/A
Reason for Recall
Due to manufacturing issues, reperfusion catheters may fractures
Distribution
Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and United Arab Emirates.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-03
Company
Livermore, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 373 device-related FDA actions this month.
Penumbra, Inc. has 19 FDA actions in our database, including 1 recall and 18 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Penumbra, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Penumbra, Inc. have FDA actions?
Penumbra, Inc. has 19 FDA actions in our database, including 1 recall and 18 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2770-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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