← FDA ENFORCEMENT
Z-2770-2026Class II

Penumbra, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Penumbra, Inc.
Product type
Device
Status
Ongoing
Report date
2026-07-29
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.
Firm state
CA
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

Due to manufacturing issues, reperfusion catheters may fractures

Product description

Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

Code / lot info

UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038

Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →