Catheter, Thrombus Retriever
FDA product code NRY · Class II (moderate risk) · 21 CFR 870.1250 · Cardiovascular
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
114510(k) clearances
0PMA approvals
26recalls
Manufacturers
- Penumbra, Inc. 25
- Concentric Medical, Inc. 16
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular 11
- Alembic, LLC 7
- Imperative Care, Inc. 7
- Rapid Medical Ltd. 6
- Perfuze, Ltd. 6
- Neuravi, Ltd. 5
- Cerenovus, Inc. 5
- Inneuroco, Inc. 3
- Route 92 Medical, Inc. 3
- MicroVention, Inc. 2
- Stryker Neurovascular 2
- Micro Therapeutics Dba Ev3 Neurovascular 2
- Wallaby Medical 2
- Q'Apel Medical, Inc. 2
- Scientia Vascular, Inc. 2
- Stryker Corporation 2
- Balt USA, LLC 2
- Suzhou Zenith Vascular SciTech Limited 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260617 | Tigertriever 13 Ultra Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 08/28/2026SE |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setNRY · Special | CERENOVUS, Inc. | 08/13/2026SE |
| K262399 | Millipede SystemNRY · Special | Perfuze, Ltd. | 08/12/2026SE |
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration TubingNRY · Special | Alembic, LLC | 08/12/2026SE |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter)NRY · Traditional | Scientia Vascular, Inc. | 07/16/2026SE |
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing)NRY · Traditional | Penumbra, Inc. | 06/10/2026SE |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing SetNRY · Traditional | Suzhou Zenith Vascular SciTech Limited | 05/20/2026SE |
| K254276 | Lynx Aspiration Catheter SystemNRY · Traditional | QApel Medical, Inc. | 05/07/2026SE |
| K253590 | Millipede SystemNRY · Traditional | Perfuze, Ltd. | 03/16/2026SE |
| K253062 | Tigertriever 25 Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 03/12/2026SE |
| K251357 | Esperance pHLO Aspiration SystemNRY · Traditional | Phenox, Ltd. | 01/15/2026SE |
| K251006 | NeVasc Aspiration SystemNRY · Traditional | Vesalio, Inc. | 11/10/2025SE |
| K252046 | Zoom System (Zoom 4S Catheter)NRY · Traditional | Imperative Care, Inc. | 10/30/2025SE |
| K251603 | Tigertriever 17 Ultra Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 10/06/2025SE |
| K251789 | EMBOTRAP III Revascularization DeviceNRY · Special | Neuravi Limited | 09/25/2025SE |
| K252392 | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetNRY · Special | Perfuze, Ltd. | 08/29/2025SE |
| K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetNRY · Special | Cerenovus, Inc. | 08/22/2025SE |
| K243948 | Raptor Aspiration Catheter; Balt Aspiration Tubing SetNRY · Traditional | Balt USA, LLC | 06/03/2025SE |
| K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingNRY · Traditional | Imperative Care, Inc. | 05/28/2025SE |
| K243601 | Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetNRY · Traditional | Route 92 Medical, Inc. | 05/19/2025SE |
| K251015 | APRO 45 Catheter and Alembic Aspiration TubingNRY · Special | Alembic, LLC | 04/30/2025SE |
| K250958 | APRO 55 Swift Catheter and Alembic Aspiration TubingNRY · Special | Alembic, LLC | 04/28/2025SE |
| K250012 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetNRY · Special | Perfuze, Ltd. | 02/26/2025SE |
| K243287 | APRO 70 Swift Catheter and Alembic Aspiration TubingNRY · Traditional | Alembic, LLC | 02/24/2025SE |
| K242104 | Penumbra System (Reperfusion Catheter RED 72)NRY · Traditional | Penumbra, Inc. | 02/13/2025SE |
| K242672 | Zoom SystemNRY · Traditional | Imperative Care, Inc. | 01/14/2025SE |
| K243080 | Riptide Aspiration SystemNRY · Special | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 10/29/2024SE |
| K241221 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus…NRY · Traditional | Cerenovus, Inc. | 10/16/2024SE |
| K240917 | Esperance 3+ Aspiration Catheter SystemNRY · Traditional | Wallaby Medical | 10/01/2024SE |
| K242504 | Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…NRY · Special | Perfuze, Ltd. | 09/20/2024SE |
| K234083 | Next Generation Aspiration Catheter; Balt Aspiration Tubing SetNRY · Traditional | Balt USA, LLC | 07/02/2024SE |
| K233329 | Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing SetNRY · Special | Route 92 Medical, Inc. | 04/23/2024SE |
| K232971 | APRO 55 Catheter and Alembic Aspiration TubingNRY · Traditional | Alembic, LLC | 02/29/2024SE |
| K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SetNRY · Special | Cerenovus, Inc. | 01/17/2024SE |
| K232524 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetNRY · Traditional | Perfuze, Ltd. | 10/18/2023SE |
| K223913 | Socrates Aspiration SystemNRY · Traditional | Scientia Vascular, Inc. | 09/20/2023SE |
| K222786 | 072 Aspiration SystemNRY · Traditional | Q'Apel Medical, Inc. | 08/25/2023SE |
| K230429 | Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device…NRY · Special | Rapid Medical Ltd. | 04/17/2023SE |
| K223530 | Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetNRY · Traditional | Route 92 Medical, Inc. | 04/11/2023SE |
| K230695 | APRO 70 Catheter and Alembic Aspiration TubingNRY · Special | Alembic, LLC | 04/10/2023SE |
| K221934 | CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing SetNRY · Traditional | Cerenovus, Inc. | 03/09/2023SE |
| K223545 | APRO 70 Catheter and Alembic Aspiration TubingNRY · Traditional | Alembic, LLC | 02/17/2023SE |
| K222808 | Penumbra System (Reperfusion Catheter RED 43)NRY · Traditional | Penumbra, Inc. | 12/20/2022SE |
| K220808 | Tigertriever 13 Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 07/25/2022SE |
| K211120 | ERIC Retrieval DeviceNRY · Traditional | MicroVention, Inc. | 03/31/2022SE |
| K211697 | Esperance Aspiration Catheter SystemNRY · Traditional | Wallaby Medical | 11/16/2021SE |
| K212908 | EmboTrap II Revascularization Device, EMBOTRAP III Revascularization DeviceNRY · Special | Neuravi, Ltd. | 10/13/2021SE |
| K211654 | Penumbra System (Reperfusion Catheter RED 72)NRY · Traditional | Penumbra, Inc. | 08/16/2021SE |
| K211338 | EMBOTRAP III Revascularization DeviceNRY · Traditional | Neuravi, Ltd. | 07/30/2021SE |
| K211411 | Penumbra System (RED 68 Reperfusion Catheter)NRY · Traditional | Penumbra, Inc. | 07/01/2021SE |
| K211476 | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingNRY · Special | Imperative Care, Inc. | 06/08/2021SE |
| K203440 | Penumbra System (Reperfusion Catheter RED 62)NRY · Traditional | Penumbra, Inc. | 05/20/2021SE |
| K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingNRY · Special | Imperative Care, Inc. | 04/23/2021SE |
| K203592 | Tigertriever and Tigertriever 17 Revascularization DevceNRY · Traditional | Rapid Medical Ltd. | 03/23/2021SE |
| K202182 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration TubingNRY · Special | Imperative Care, Inc. | 09/02/2020SE |
| K202251 | Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra…NRY · Special | Penumbra, Inc. | 08/31/2020SE |
| K201689 | Riptide Aspiration SystemNRY · Special | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 07/21/2020SE |
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetNRY · Traditional | Codman & Shurtleff, Inc. | 07/20/2020SE |
| K193063 | EMBOTRAP III Revascularization DeviceNRY · Traditional | Neuravi, Ltd. | 07/14/2020SE |
| K191946 | Penumbra System Penumbra JET 7XNRY · Traditional | Penumbra, Inc. | 02/27/2020SE |
| K190338 | 046 Zenith FlexNRY · Traditional | Inneuroco, Inc. | 08/02/2019SE |
| K191768 | AXS Vecta Aspiration SystemNRY · Special | Stryker Neurovascular | 07/30/2019SE |
| K190010 | Penumbra System Reperfusion Catheter JET 7NRY · Traditional | Penumbra, Inc. | 06/16/2019SE |
| K190464 | Penumbra System 3D Revascularization DeviceNRY · Traditional | Penumbra, Inc. | 04/26/2019SE |
| K190212 | AXS Vecta Aspiration SystemNRY · Special | Stryker Neurovascular | 04/24/2019SE |
| K183043 | 0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045…NRY · Traditional | Imperative Care, Inc. | 04/17/2019SE |
| K183464 | AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)NRY · Traditional | Stryker | 03/13/2019SE |
| K183185 | Riptide Aspiration System (Riptide Large Bore Aspiration System)NRY · Special | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 12/18/2018SE |
| K182101 | Riptide Aspiration System (React 71 Catheter)NRY · Traditional | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 11/14/2018SE |
| K181354 | 074 Zenith Flex SystemNRY · Traditional | Inneuroco, Inc. | 10/25/2018SE |
| K182522 | Penumbra System (Modified 110 Aspiration Tubing)NRY · Special | Penumbra, Inc. | 10/12/2018SE |
| K173761 | Penumbra System Reperfusion Catheter JET 7NRY · Traditional | Penumbra, Inc. | 08/17/2018SE |
| K180705 | Riptide Aspiration System React 68 CatheterNRY · Traditional | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 07/04/2018SE |
| K180008 | Penumbra SystemNRY · Traditional | Penumbra, Inc. | 06/20/2018SE |
| K173200 | SOFIA Plus Aspiration CatheterNRY · Traditional | MicroVention, Inc. | 06/11/2018SE |
| K173452 | EmboTrap ll Revascularization DeviceNRY · Traditional | Neuravi, Ltd. | 05/09/2018SE |
| K172167 | Zenith Flex SystemNRY · Traditional | Inneuroco, Inc. | 04/19/2018SE |
| K173841 | AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058…NRY · Traditional | Stryker | 03/18/2018SE |
| K172448 | Riptide Aspiration SystemNRY · Traditional | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 12/21/2017SE |
| K162901 | Penumbra 3D Revascularization DeviceNRY · Traditional | Penumbra, Inc. | 04/20/2017SE |
| K160641 | Solitaire Platinum Revascularization Device, 6x40 mmNRY · Traditional | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 03/08/2017SE |
| K161879 | Solitaire Platinum Revascularization DeviceNRY · Special | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 09/21/2016SE |
| K161640 | Penumbra System ACE 68 Reperfusion CatheterNRY · Special | Penumbra, Inc. | 07/12/2016SE |
| K161064 | Penumbra System ACE 68 Reperfusion CatheterNRY · Special | Penumbra, Inc. | 06/12/2016SE |
| K160449 | Penumbra System, Penumbra Pump MAXNRY · Traditional | Penumbra, Inc. | 05/25/2016SE |
| K152541 | Penumbra System ACE 64 and ACE 68 Reperfusion CathetersNRY · Traditional | Penumbra, Inc. | 01/13/2016SE |
| K153071 | Solitaire Platinum Revascularization DeviceNRY · Special | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 12/23/2015SE |
| K151623 | Penumbra System 110 Aspiration TubingNRY · Special | Penumbra, Inc. | 08/06/2015SE |
| K150616 | Trevo XP ProVue Retriever (4x30mm)NRY · Traditional | Concentric Medical, Inc. | 06/12/2015SE |
| K142458 | Penumbra System ACENRY · Traditional | Penumbra, Inc. | 05/22/2015SE |
| K143077 | Trevo XP ProVue Retriever (6X25mm)NRY · Traditional | Concentric Medical, Inc. | 04/06/2015SE |
| K141516 | Mindframe Capture LP Revascularization DeviceNRY · Traditional | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 02/05/2015SE |
| K141491 | Solitaire 2 Revascularization DeviceNRY · Traditional | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 10/22/2014SE |
| K133317 | Penumbra System / Penumbra System MaxNRY · Traditional | Penumbra, Inc. | 05/13/2014SE |
| K133464 | Modified Trevo Provue RetrieverNRY · Special | Concentric Medical, Inc. | 01/17/2014SE |
| K132641 | Modified Trevo Provue RetrieverNRY · Traditional | Concentric Medical, Inc. | 01/13/2014SE |
| K123378 | Solitaire 2 Revascularization DeviceNRY · Special | Micro Therapeutics Dba Ev3 Neurovascular | 11/30/2012SE |
| K122478 | Modified Trevo RetrieverNRY · Traditional | Concentric Medical, Inc. | 10/31/2012SE |
| K120961 | Trevo RetrieverNRY · Traditional | Concentric Medical, Inc. | 08/03/2012SE |
| K113455 | Solitaire FR Revascularization DeviceNRY · Traditional | Micro Therapeutics Dba Ev3 Neurovascular | 03/02/2012SE |
| K113163 | Penumbra System MaxNRY · Special | Penumbra, Inc. | 11/23/2011SE |
| K093610 | Modified Retriever (Modified, Line Extension), Models 90152, 90153NRY · Traditional | Concentric Medical, Inc. | 02/17/2011SE |
| K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032, PSF041, PSF054NRY · Special | Penumbra, Inc. | 05/21/2010SE |
| K090752 | Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator…NRY · Traditional | Penumbra, Inc. | 09/21/2009SE |
| K090085 | Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113NRY · Special | Concentric Medical, Inc. | 02/12/2009SE |
| K082034 | Modification to Merci RetrieverNRY · Special | Concentric Medical, Inc. | 08/15/2008SE |
| K081305 | Merci RetrieverNRY · Special | Concentric Medical, Inc. | 06/05/2008SE |
| K072718 | Penumbra SystemNRY · Traditional | Penumbra, Inc. | 12/28/2007SE |
| K071172 | Modified Merci Retriever, Model 90060NRY · Traditional | Concentric Medical, Inc. | 08/22/2007SE |
| K070521 | Modified Mercy Retriever, Model 90070NRY · Special | Concentric Medical, Inc. | 04/24/2007SE |
| K063774 | Modification to Merci Retriever, Models X5 and X6NRY · Special | Concentric Medical, Inc. | 01/24/2007SE |
| K062046 | Modified Merci Retriever, Model 90050NRY · Traditional | Concentric Medical, Inc. | 01/19/2007SE |
| K061059 | Modified Merci Retriever, Model 90092NRY · Special | Concentric Medical, Inc. | 05/25/2006SE |
| K033736 | Merci Retriever, Models 90065, 90066NRY · Traditional | Concentric Medical, Inc. | 08/11/2004SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2770-2026 Class II | Penumbra System RED 68 Reperfusion Catheter REF: RED68KITDue to manufacturing issues, reperfusion catheters may fractures | Penumbra, Inc. | 06/03/2026Open, Classified |
| Z-1512-2025 Class I | Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF:…Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip… | Qapel Medical Inc. | 02/26/2025Open, Classified |
| Z-1234-2025 Class II | Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration…Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a… | Scientia Vascular, Inc. | 01/02/2025Open, Classified |
| Z-3157-2024 Class II | ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a…Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3… | Microvention Inc. | 08/05/2024Open, Classified |
| Z-1903-2024 Class II | Trevo ProVue, Catalog: 90184Neurovascular devices did not meet the minimum sample size required for endotoxin testing during… | Stryker Neurovascular | 04/23/2024Open, Classified |
| Z-1611-2024 Class I | Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used…Their is the potential for distal tip separation at the proximal marker band of the delivery catheters | Route 92 Medical Inc | 03/08/2024Open, Classified |
| Z-2577-2021 Class I | Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F…There is a potential for distal end of catheters to fracture and become detached. | Imperative Care Inc | 08/13/2021Completed |
| Z-0851-2021 Class I | Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow…The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with… | Penumbra Inc. | 12/15/2020Terminated |
| Z-0850-2021 Class I | Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF…The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with… | Penumbra Inc. | 12/15/2020Terminated |
| Z-0849-2021 Class I | Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF…The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with… | Penumbra Inc. | 12/15/2020Terminated |
| Z-0848-2021 Class I | Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter…The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with… | Penumbra Inc. | 12/15/2020Terminated |
| Z-1621-2020 Class II | Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115…The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if… | Stryker Neurovascular | 04/10/2019Terminated |
| Z-1620-2020 Class II | Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115…The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if… | Stryker Neurovascular | 04/10/2019Terminated |
| Z-1701-2018 Class I | MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF…There is a potential issue for all MindFrame Capture devices to partially detach or separate from the… | Micro Therapeutics Inc, Dba Ev3 Neurovascular | 02/26/2018Terminated |
| Z-0347-2018 Class II | Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo…Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where… | Stryker Neurovascular | 11/28/2017Terminated |
| Z-0277-2018 Class II | Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm…Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were… | Stryker Neurovascular | 11/03/2017Terminated |
| Z-0276-2018 Class II | Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm…Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were… | Stryker Neurovascular | 11/03/2017Terminated |
| Z-0275-2018 Class II | Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm…Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were… | Stryker Neurovascular | 11/03/2017Terminated |
| Z-2802-2017 Class II | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US…Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton… | Stryker Neurovascular | 06/26/2017Terminated |
| Z-2801-2017 Class II | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS…Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton… | Stryker Neurovascular | 06/26/2017Terminated |
| Z-2800-2017 Class II | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS…Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton… | Stryker Neurovascular | 06/26/2017Terminated |
| Z-2799-2017 Class II | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS…Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton… | Stryker Neurovascular | 06/26/2017Terminated |
| Z-2702-2017 Class I | Penumbra 3D Revascularization Device It is indicated for used in the revascularization…Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire.… | Penumbra Inc. | 06/09/2017Terminated |
| Z-2598-2014 Class II | Merci Retriever Intended to restore blood flow in the neurovasculature by removing…Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with… | Concentric Medical Inc | 06/25/2014Terminated |
| Z-0528-2015 Class II | Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo…Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not… | Concentric Medical Inc | 11/13/2013Terminated |
| Z-0428-2011 | Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020…Reperfusion catheter may fail at the mid-shaft joint and may break off. If the segment cannot be removed, it… | Penumbra Inc. | 10/25/2010Terminated |