- Recalling firm
- Penumbra, Inc.
- Reason for recall
- Due to manufacturing issues, reperfusion catheters may fractures
- Affected products (lot / model / serial)
- UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
- Units affected
- N/A
- Distribution pattern
- 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 location
- Livermore, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2770-2026
- Recall initiated
- June 3, 2026
- FDA classification date
- July 21, 2026
- FDA report date
- July 29, 2026
- FDA event ID
- 99148
- Last updated on HTM Vibe
- August 4, 2026