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

Due to manufacturing issues reperfusion catheters may fracture.

On 07/24/2026, an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" was sent via email and FedEx Priority Overnight to customers informing them that Penumbra has identified an issue (frature) in the lot H00007856 of the Penumbra System RED 62 Reperfusion Catheter (RED 62). Actions Customers need to take: " Share this Recall Notification with all users of the product within your facility " Review inventory for the specified lot listed above " If you do have inventory of the specified lot listed above, remove affected units from inventory and place in quarantine for return to Penumbra, Inc. Complete and return the Product Identification/Return Notification to [email protected] within 3 business days. Your Penumbra Sales Representative will work with you directly to arrange return and credit. " If you do not have inventory of the specified lot listed above, complete and return the Product Identification/Return Notification form to [email protected] within 3 business days. No further action is required. For questions - contact Penumbra Sales Representative or email at [email protected].