Class IIDeviceOngoing

Penumbra Inc.

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

Reason for recall

Due to manufacturing issues reperfusion catheters may fracture.

Details

Recall number: Z-3331-2026
Event ID: 99591
Recall initiated: Jul 24, 2026
Classified: Sep 29, 2026
Reported: Oct 7, 2026
Quantity: 43
Distribution: US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Alameda, CA, United States
Lot / code info: Lot Code: UDI: 00815948024359 Lot Number: H00007856