TemporaryFDAOngoing
Can cause harm that is usually temporary.
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
Check the device or its packaging for
Lot Code: UDI: 00815948024359 Lot Number: H00007856
- Why
- Due to manufacturing issues reperfusion catheters may fracture.
- Distributed
- US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
- Company
- Penumbra Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3331-2026 · retrieved 29 September 2026
Read the official notice