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Penumbra Inc.: Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number

Medical DevicesSource: FDA (device) · Date: 2026-10-07

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Penumbra Inc.
Product
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 / hazard
Due to manufacturing issues reperfusion catheters may fracture.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI.
Recall initiated
2026-07-24
Code info
Lot Code: UDI: 00815948024359 Lot Number: H00007856
Product quantity
43
Voluntary mandated
Voluntary: Firm initiated
City
Alameda
State
CA
Country
United States
Event id
99591
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