Penumbra Inc.

FDA Regulatory Profile

Summary

Total Recalls
5 (5 Class I)
510(k) Clearances
85
Inspections
10
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0849-2021Class IPenumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The PDecember 15, 2020
Z-0851-2021Class IPenumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration December 15, 2020
Z-0848-2021Class IPenumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with XtrDecember 15, 2020
Z-0850-2021Class IPenumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT TDecember 15, 2020
Z-2702-2017Class IPenumbra 3D Revascularization Device It is indicated for used in the revascularization of patients June 9, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKFebruary 5, 2026
K252612INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – LightningOctober 16, 2025
K250079Ruby XL SystemMarch 14, 2025
K242104Penumbra System (Reperfusion Catheter RED 72)February 13, 2025
K242033Access25™ Delivery MicrocatheterDecember 11, 2024
K242520Element Vascular Access SystemNovember 20, 2024
K242075Indigo® Aspiration System – Lightning Bolt Aspiration TubingSeptember 25, 2024
K242319Indigo® Aspiration System – Aspiration Catheter 6XSeptember 3, 2024
K241399Indigo® Lightning Flash Aspiration System – Select +™ CatheterJune 10, 2024
K233201MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)March 27, 2024
K240030Indigo® Aspiration System - Lightning® FlashFebruary 2, 2024
K230284Penumbra LP Coil SystemOctober 25, 2023
K223186Indigo® Aspiration System – Lightning Bolt Aspiration TubingFebruary 13, 2023
K222808Penumbra System (Reperfusion Catheter RED 43)December 20, 2022
K222358Indigo Aspiration System - Lightning FlashDecember 20, 2022
K221822BENCHMARK BMX81 Access SystemNovember 4, 2022
K220683INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)October 4, 2022
K213390Benchmark BMX96 Access SystemAugust 18, 2022
K212838Benchmark Intracranial Access SystemMay 27, 2022
K211654Penumbra System (Reperfusion Catheter RED 72)August 16, 2021