Penumbra, Inc. — Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
⚠️ Due to manufacturing issues, reperfusion catheters may fractures
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 3, 2026
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.
What's affected?
- Product
- Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- Brand
- Penumbra, Inc.
- Lot code
- H00008699
Additional details
UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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