FDA Device recall Z-3331-2026
Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number:…
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog Number:… by Penumbra, citing due to manufacturing issues reperfusion catheters may fracture.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3331-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-24 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Penumbra |
| Distribution | US |
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
Due to manufacturing issues reperfusion catheters may fracture.
Identifiers
| code_info | Lot Code: UDI: 00815948024359 Lot Number: H00007856 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Penumbra
- Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
FDA Device · Class II · 2026-07-29 · Penumbra - Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a c…
FDA Device · Class I · 2021-01-27 · Penumbra - Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with…
FDA Device · Class I · 2021-01-27 · Penumbra - Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7…
FDA Device · Class I · 2021-01-27 · Penumbra - Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtr…
FDA Device · Class I · 2021-01-27 · Penumbra
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3331-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.