Penumbra Inc.
Alameda, CA, US
Penumbra Inc. appears in FDA device records in Alameda, CA. FDA records list 87 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 87FDA records hold 87 510(k) clearances for Penumbra Inc. between 2005 and 2026. The busiest year on record is 2016, with 9. The most recent is 2026, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 3 |
| 2012 | 4 |
| 2014 | 3 |
| 2015 | 7 |
| 2016 | 9 |
| 2017 | 4 |
| 2018 | 7 |
| 2019 | 6 |
| 2020 | 8 |
| 2021 | 5 |
| 2022 | 6 |
| 2023 | 2 |
| 2024 | 7 |
| 2025 | 3 |
| 2026 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing) | NRY | Substantially Equivalent | |
| K260599 | INDIGO® Aspiration System – INDIGO Link | QEW | Substantially Equivalent | |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | QEW | Substantially Equivalent | |
| K252612 | INDIGO® Aspiration System – Lightning Flash Aspiration Tubing; INDIGO® Aspiration System – Lightning Bolt Aspiration Tubing | QEW | Substantially Equivalent | |
| K250079 | Ruby XL System | KRD | Substantially Equivalent | |
| K242104 | Penumbra System (Reperfusion Catheter RED 72) | NRY | Substantially Equivalent | |
| K242033 | Access25™ Delivery Microcatheter | QJP | Substantially Equivalent | |
| K242520 | Element Vascular Access System | DYB | Substantially Equivalent | |
| K242075 | Indigo® Aspiration System – Lightning Bolt Aspiration Tubing | QEW | Substantially Equivalent | |
| K242319 | Indigo® Aspiration System – Aspiration Catheter 6X | QEW | Substantially Equivalent | |
| K241399 | Indigo® Lightning Flash Aspiration System – Select +™ Catheter | QEW | Substantially Equivalent | |
| K233201 | MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) | QJP | Substantially Equivalent | |
| K240030 | Indigo® Aspiration System - Lightning® Flash | QEW | Substantially Equivalent | |
| K230284 | Penumbra LP Coil System | HCG | Substantially Equivalent | |
| K223186 | Indigo® Aspiration System – Lightning Bolt Aspiration Tubing | QEW | Substantially Equivalent | |
| K222808 | Penumbra System (Reperfusion Catheter RED 43) | NRY | Substantially Equivalent | |
| K222358 | Indigo Aspiration System - Lightning Flash | QEW | Substantially Equivalent | |
| K221822 | BENCHMARK BMX81 Access System | QJP | Substantially Equivalent | |
| K220683 | INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) | QEW | Unknown | |
| K213390 | Benchmark BMX96 Access System | QJP | Substantially Equivalent | |
| K212838 | Benchmark Intracranial Access System | QJP | Substantially Equivalent | |
| K211654 | Penumbra System (Reperfusion Catheter RED 72) | NRY | Substantially Equivalent | |
| K211411 | Penumbra System (RED 68 Reperfusion Catheter) | NRY | Substantially Equivalent | |
| K203440 | Penumbra System (Reperfusion Catheter RED 62) | NRY | Substantially Equivalent | |
| K210323 | Indigo Aspiration System - Lightning Aspiration Tubing | QEW | Substantially Equivalent | |
| K210083 | Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 | QEW | Substantially Equivalent | |
| K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 | QEW | Substantially Equivalent | |
| K202251 | Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) | NRY | Substantially Equivalent | |
| K193595 | Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 | QEW | Substantially Equivalent | |
| K201271 | Benchmark BMX96 Access System | DQY | Substantially Equivalent | |
| K192981 | Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 | QEW | Substantially Equivalent | |
| K200771 | Indigo Aspiration System Lightning Aspiration Tubing | QEW | Substantially Equivalent | |
| K193244 | Indigo Aspiration System – Lightning Aspiration Tubing | QEW | Substantially Equivalent | |
| K191946 | Penumbra System Penumbra JET 7X | NRY | Substantially Equivalent | |
| K192833 | Indigo Aspiration System | QEW | Substantially Equivalent | |
| K192955 | Penumbra LP Coil System | HCG | Substantially Equivalent | |
| K190719 | Artemis Eye System | GWG | Substantially Equivalent | |
| K190010 | Penumbra System Reperfusion Catheter JET 7 | NRY | Substantially Equivalent | |
| K190464 | Penumbra System 3D Revascularization Device | NRY | Substantially Equivalent | |
| K183296 | REAL Immersive System | ISD | Substantially Equivalent | |
| K182522 | Penumbra System (Modified 110 Aspiration Tubing) | NRY | Substantially Equivalent | |
| K173761 | Penumbra System Reperfusion Catheter JET 7 | NRY | Substantially Equivalent | |
| K180008 | Penumbra System | NRY | Substantially Equivalent | |
| K180412 | Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister | QEW | Substantially Equivalent | |
| K180939 | Indigo Aspiration System - Modified 110 Aspiration Tubing | QEW | Substantially Equivalent | |
| K173614 | Penumbra Coil 400, Ruby Coil System, POD System | HCG | Substantially Equivalent | |
| K180105 | Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister | QEW | Substantially Equivalent | |
| K171332 | Artemis Neuro Evacuation Device | GWG | Substantially Equivalent | |
| K170852 | POD Packing Coil | HCG | Substantially Equivalent | |
| K163618 | INDIGO Aspiration System | QEX | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005168196 | 3005168196 | PENUMBRA, INC. | One Penumbra Place, Alameda, CA 94502 US | 2026 | and 1 more, listed in full below |
| 3013758550 | 3013758550 | Penumbra Inc. | 6262 Patterson Pass Rd., Suite E, Suite F, Livermore, CA 94550 US | 2026 | and 1 more, listed in full below |
| 3015615738 | 3015615738 | Penumbra Inc. | 1070 SOUTH 3800 WEST, Salt Lake City, UT 84104 US | 2026 | and 1 more, listed in full below |
| 3016591327 | 3016591327 | Penumbra Inc. | 630 Roseville Parkway, Roseville, CA 95747 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- LITCatheter, Angioplasty, Peripheral, Transluminal
- DQYCatheter, Percutaneous
- QJPCatheter, Percutaneous, Neurovasculature
- NRYCatheter, Thrombus Retriever
- QEXCoronary Mechanical Thrombectomy With Aspiration
- HCGDevice, Neurovascular Embolization
- KRDDevice, Vascular, For Promoting Embolization
- GWGEndoscope, Neurological
- ISDExerciser, Measuring
- DYBIntroducer, Catheter
- QEWPeripheral Mechanical Thrombectomy With Aspiration
- BTAPump, Portable, Aspiration (Manual Or Powered)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2770-2026 | Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT | Due to manufacturing issues, reperfusion catheters may fractures | Class II | Open, Classified | |
| Z-0851-2021 | Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death. | Class I | Terminated | |
| Z-0850-2021 | Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death. | Class I | Terminated | |
| Z-0849-2021 | Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death. | Class I | Terminated | |
| Z-0848-2021 | Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. | The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death. | Class I | Terminated | |
| Z-2702-2017 | Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. | Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death. | Class I | Terminated | |
| Z-1906-2011 | Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA The Penumbra Coil System (Penumbra Coil 400 TM) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae. The coils are also intended for arterial and venous embolization in the peripheral vasculature. The coils function to selectively embolize aneurysms or targeted segments of the vasculature by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Penumbra Coil System is compatible with the Penumbra PX 400 Microcatheter. | The diameter of a component of the device is out of tolerance specification; the Delivery Pusher pull wire which secures the coil in place can prolapse and allow premature detachment of the coil. | Terminated | ||
| Z-0428-2011 | Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA. | Reperfusion catheter may fail at the mid-shaft joint and may break off. If the segment cannot be removed, it may result in blocked blood flow, requiring emergency medical treatment. | Terminated | ||
| Z-0001-2010 | Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. | Failure-- product can kink or ovalize, which may result in difficulty in catheter advancement or delivery of other devices and damage to catheter, which could lead to patient injury or death as a result of portions being retained in the patient. | Terminated | ||
| Z-2049-2009 | Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature. | Leakage-- Due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage. | Terminated | ||
| Z-2313-2009 | Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA Percutaneous Catheter, indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature. | Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery' | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain