TemporaryFDAOngoing
Can cause harm that is usually temporary.
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Check the device or its packaging for
UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
- Why
- Due to manufacturing issues, reperfusion catheters may fractures
- Distributed
- 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.
- Company
- Penumbra, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2770-2026 · retrieved 21 July 2026
Read the official notice