Penumbra, Inc.: Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Penumbra, Inc.
- Product
- Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- Reason / hazard
- Due to manufacturing issues, reperfusion catheters may fractures
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-06-03
- Code info
- UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
- Product quantity
- N/A
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Livermore
- State
- CA
- Country
- United States
- Event id
- 99148
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