Penumbra System RED 68 Reperfusion Catheter
The Penumbra System RED 68 Reperfusion Catheter may fracture due to manufacturing issues.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Penumbra, Inc., of Livermore, California, began a recall of the Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT on June 3, 2026, because manufacturing issues may cause the catheter to fracture. The FDA added the recall to its Enforcement Report and classified it on July 21, 2026, with the recall in the FDA's weekly enforcement report on July 29, 2026.
The product was distributed nationwide in the United States, including states and territories such as 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, and Puerto Rico, as well as to Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and the United Arab Emirates.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the UDI-DI and lot code listed under your product.
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- UDI-DI
- 00815948024113
- Lot
- H00008699
- H00008701
- H00008702
- H00008703
- C00020038
Details
- Company began the recall
- Sold in
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.
- Event ID
- 99148
- Recall No.
- Z-2770-2026
- Company
- Penumbra, Inc.Livermore, California
- Hazard
- Manufacturing deviation
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
