Penumbra System (RED 62 Reperfusion Catheter)
The Penumbra System (RED 62 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. began a recall of the Penumbra System (RED 62 Reperfusion Catheter) on July 24, 2026, because manufacturing issues may cause the reperfusion catheter to fracture. The FDA added the recall to its Enforcement Report on September 29, 2026, and classified it on the same date.
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 yours affected?
Match the model number and lot code listed under your product.
Penumbra System (RED 62 Reperfusion Catheter)
- Model
- THNDRRED62SKIT
- Lot
- H00007856
Details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Alabama, California, Colorado, Florida, Louisiana, North Carolina, New York, Texas, Utah, Wisconsin.
- Event ID
- 99591
- Recall No.
- Z-3331-2026
- Company
- Penumbra Inc.Alameda, California
- Hazard
- Manufacturing deviation
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
