Penumbra Inc.
FDA Regulatory Profile
Penumbra Inc. appears in FDA public data with 5 recalls — including 5 Class I (most serious) —, 87 510(k) clearances, 10 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0849-2021, Class I) was initiated on December 15, 2020. Its most recent 510(k) clearance was granted on June 10, 2026.
Summary
- Total Recalls
- 5 (5 Class I)
- 510(k) Clearances
- 87
- Inspections
- 10
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0849-2021 | Class I | Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The P | December 15, 2020 |
| Z-0851-2021 | Class I | Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration | December 15, 2020 |
| Z-0848-2021 | Class I | Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtr | December 15, 2020 |
| Z-0850-2021 | Class I | Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT T | December 15, 2020 |
| Z-2702-2017 | Class I | Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients | June 9, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing) | June 10, 2026 |
| K260599 | INDIGO® Aspiration System INDIGO Link | April 24, 2026 |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | February 5, 2026 |
| K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning | October 16, 2025 |
| K250079 | Ruby XL System | March 14, 2025 |
| K242104 | Penumbra System (Reperfusion Catheter RED 72) | February 13, 2025 |
| K242033 | Access25 Delivery Microcatheter | December 11, 2024 |
| K242520 | Element Vascular Access System | November 20, 2024 |
| K242075 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing | September 25, 2024 |
| K242319 | Indigo® Aspiration System Aspiration Catheter 6X | September 3, 2024 |
| K241399 | Indigo® Lightning Flash Aspiration System Select + Catheter | June 10, 2024 |
| K233201 | MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) | March 27, 2024 |
| K240030 | Indigo® Aspiration System - Lightning® Flash | February 2, 2024 |
| K230284 | Penumbra LP Coil System | October 25, 2023 |
| K223186 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing | February 13, 2023 |
| K222358 | Indigo Aspiration System - Lightning Flash | December 20, 2022 |
| K222808 | Penumbra System (Reperfusion Catheter RED 43) | December 20, 2022 |
| K221822 | BENCHMARK BMX81 Access System | November 4, 2022 |
| K220683 | INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) | October 4, 2022 |
| K213390 | Benchmark BMX96 Access System | August 18, 2022 |