Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT recall (Penumbra, Inc.)
Medical deviceClass IIOngoing
Summary: Penumbra, Inc. is recalling Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT. Reason: Due to manufacturing issues, reperfusion catheters may fractures.
What is being recalled
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Why
Due to manufacturing issues, reperfusion catheters may fractures
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin)
How to tell if yours is affected
UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2770-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 3, 2026 |
| Reported | July 29, 2026 |
| Company | Penumbra, Inc. |
| Company location | Livermore, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | N/A |
More recalls from Penumbra, Inc. · all medical device recalls · recalls from June 2026