Recall Z-3331-2026— Penumbra Inc.
Class II · Ongoing
Class II FDA medical device recall by Penumbra Inc., initiated 2026-07-24. It names 2 FDA 510(k) clearances: K250690, K203440. 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..
- Recalling firm
- Penumbra Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-24
- Firm location
- Alameda, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K250690 — Penumbra System (Thunderbolt Aspiration Tubing)
- K203440 — Penumbra System (Reperfusion Catheter RED 62)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.