Penumbra, Inc.
Penumbra, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2026, with 6 FDA device recalls on record.
Top product codes for Penumbra, Inc.
FDA recalls by Penumbra, Inc.
- Z-2770-2026 — Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- 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.
- 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.
- 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.
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Penumbra, Inc.
- K250690 — Penumbra System (Thunderbolt Aspiration Tubing)
- K260599 — INDIGO® Aspiration System INDIGO Link
- K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
- K252612 — INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing
- K250079 — Ruby XL System
- K242104 — Penumbra System (Reperfusion Catheter RED 72)
- K242033 — Access25 Delivery Microcatheter
- K242520 — Element Vascular Access System
- K242075 — Indigo® Aspiration System Lightning Bolt Aspiration Tubing
- K242319 — Indigo® Aspiration System Aspiration Catheter 6X
- K241399 — Indigo® Lightning Flash Aspiration System Select + Catheter
- K233201 — MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)
- K240030 — Indigo® Aspiration System - Lightning® Flash
- K230284 — Penumbra LP Coil System
- K223186 — Indigo® Aspiration System Lightning Bolt Aspiration Tubing
- K222358 — Indigo Aspiration System - Lightning Flash
- K222808 — Penumbra System (Reperfusion Catheter RED 43)
- K221822 — BENCHMARK BMX81 Access System
- K220683 — INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
- K213390 — Benchmark BMX96 Access System
- K212838 — Benchmark Intracranial Access System
- K211654 — Penumbra System (Reperfusion Catheter RED 72)
- K211411 — Penumbra System (RED 68 Reperfusion Catheter)
- K203440 — Penumbra System (Reperfusion Catheter RED 62)
- K210323 — Indigo Aspiration System - Lightning Aspiration Tubing
- K210083 — Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7
- K202821 — Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
- K202251 — Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)
- K193595 — Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
- K201271 — Benchmark BMX96 Access System
- K192981 — Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
- K200771 — Indigo Aspiration System Lightning Aspiration Tubing
- K193244 — Indigo Aspiration System Lightning Aspiration Tubing
- K191946 — Penumbra System Penumbra JET 7X
- K192833 — Indigo Aspiration System
- K192955 — Penumbra LP Coil System
- K190719 — Artemis Eye System
- K190010 — Penumbra System Reperfusion Catheter JET 7
- K190464 — Penumbra System 3D Revascularization Device
- K183296 — REAL Immersive System
- K182522 — Penumbra System (Modified 110 Aspiration Tubing)
- K173761 — Penumbra System Reperfusion Catheter JET 7
- K180008 — Penumbra System
- K180412 — Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister
- K180939 — Indigo Aspiration System - Modified 110 Aspiration Tubing
- K173614 — Penumbra Coil 400, Ruby Coil System, POD System
- K180105 — Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister
- K171332 — Artemis Neuro Evacuation Device
- K170852 — POD Packing Coil
- K163618 — INDIGO Aspiration System
- K162901 — Penumbra 3D Revascularization Device
- K161506 — Penumbra Aspiration System
- K161640 — Penumbra System ACE 68 Reperfusion Catheter
- K161523 — INDIGO Aspiration System
- K161064 — Penumbra System ACE 68 Reperfusion Catheter
- K160449 — Penumbra System, Penumbra Pump MAX
- K160533 — Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
- K160832 — Penumbra Smart Coil
- K152699 — Apollo System
- K152541 — Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
- K152840 — Lantern Delivery Microcatheter
- K151623 — Penumbra System 110 Aspiration Tubing
- K151572 — Penumbra Smart Coil
- K142870 — Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
- K142458 — Penumbra System ACE
- K143218 — Penumbra Smart Coil
- K142321 — Benchmark Intracranial Access System
- K141134 — POD SYSTEM
- K133317 — PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
- K132931 — APOLLO SYSTEM
- K122772 — PENUMBRA DDC CATHETERS
- K122756 — PENUMBRA PUMP MAX (110VAC), PENUMBRA PUMP MAX (230VAC), PENUMBAR PUMP MAX CANISTER/TUBING
- K121917 — PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM
- K120330 — PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
- K113163 — PENUMBRA SYSTEM MAX
- K111380 — NEURON MAX SYSTEM
- K103305 — PENUMBRA EMBOLIZATION COIL SYSTEM
- K100826 — PENUMBRA CATHERER 025
- K100769 — PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054
- K093970 — PICA CATHETER
- K090752 — PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054
- K083125 — NEURON SELECT CATHETER SIZE 070
- K082290 — NEURON DELIVERY CATHETER 070
- K072718 — PENUMBRA SYSTEM
- K070970 — NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F
- K053491 — PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F
- K051758 — PENUMBRA ASPIRATION PUMP, MODEL 115V
Data sourced from openFDA. This site is unofficial and independent of the FDA.