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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

Class II
Recalling firm
Penumbra Inc.
Reason for recall
Due to manufacturing issues reperfusion catheters may fracture.
Affected products (lot / model / serial)
Lot Code: UDI: 00815948024359 Lot Number: H00007856
Units affected
43
Distribution pattern
US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
Firm location
Alameda, CA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-3331-2026
Recall initiated
July 24, 2026
FDA classification date
September 29, 2026
FDA report date
October 7, 2026
FDA event ID
99591
Last updated on HTM Vibe
October 13, 2026
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