Recall Z-3331-2026 ยท NRY Catheter, Thrombus Retriever
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
| Date | Sep 29, 2026 (initiated Jul 24, 2026) |
| Status | Open, Classified |
| Reason | Due to manufacturing issues reperfusion catheters may fracture. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 43 |
| Distribution | US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI. |
| FDA record | Open on fda.gov |