Brand Name: Penumbra System recall (Penumbra Inc.)
Medical deviceClass IIOngoing
Summary: Penumbra Inc. is recalling Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Software Version: N/A Product Description: Product common name: Percutaneous catheter A complete product description is provided in Attach. Reason: Due to manufacturing issues reperfusion catheters may fracture.
What is being recalled
Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number: THNDRRED62SKIT Software Version: N/A Product Description: Product common name: Percutaneous catheter A complete product description is provided in Attachment 1 (HHE-2026-002 RED62). Component: Penumbra System
Why
Due to manufacturing issues reperfusion catheters may fracture.
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
US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI. (states named: Alabama, California, Colorado, Florida, Louisiana, North Carolina, New York, Texas, Utah, Wisconsin)
How to tell if yours is affected
Lot Code: UDI: 00815948024359 Lot Number: H00007856
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-3331-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 24, 2026 |
| Reported | October 7, 2026 |
| Company | Penumbra Inc. |
| Company location | Alameda, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 43 |
More recalls from Penumbra Inc. · all medical device recalls · recalls from July 2026