Official recall notice

FDA DeviceClass IINotable

Penumbra System Recall (Oct 2026)

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

Recall date
2026-10-07
FDA class
Class II

Why it was recalled

Hazard

Due to manufacturing issues reperfusion catheters may fracture.

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Product description

Due to manufacturing issues reperfusion catheters may fracture.

Affected products

Lot Code: UDI: 00815948024359 Lot Number: H00007856

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