FDA-Device2026-10-07Class IIPROCESSING DEFECT
Penumbra System RED 62 Reperfusion Catheter recalled for fracture risk due to manufacturing defect
What this means
Penumbra Inc. is recalling the Penumbra System RED 62 Reperfusion Catheter due to a manufacturing issue that may cause the catheter to fracture during use. The recall affects 43 units distributed across multiple U.S. states. No injuries have been reported to date.
- If you have this catheter in inventory, stop using it immediately and contact Penumbra Inc.
- Check your lot number against H00007856 (UDI: 00815948024359) to confirm if your units are affected.
- Return affected catheters to Penumbra Inc. or your supplier for replacement or refund.
The agency's original wording
Hazard
Due to manufacturing issues reperfusion catheters may fracture.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
Affected count
43
Manufactured in
1 Penumbra, Alameda, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3331-2026Want us to check the next one for you?
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