Device recall
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
- Recall number
- Z-3331-2026
- Event id
- 99591
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Penumbra Inc.
- Report date
- Oct 7, 2026
- Posted
- Sep 29, 2026
- Initiated
- Jul 24, 2026
- Center classification date
- Sep 29, 2026
- Product code
- NRY
- Device type
- Catheter, Thrombus Retriever
- Reason
- Due to manufacturing issues reperfusion catheters may fracture.
- Root cause
- Under Investigation by firm
- Quantity
- 43
- Code info
- Lot Code: UDI: 00815948024359 Lot Number: H00007856
- Distribution
- US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Alameda, CA, United States