Medical Device

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

Recall date: 2026-10-07 · Source: FDA_DEVICE

Brand / Firm

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 for recall

Due to manufacturing issues reperfusion catheters may fracture.

Units affected

Description

View official recall notice →