Data / Medical devices / United States / Stryker Neurovascular
Stryker Neurovascular: FDA-registered device maker in Fremont, CA, United States, 67 510(k) clearances and 2 PMA approvals
Stryker Neurovascular is registered with the FDA (registration 3008853977) in Fremont, CA, United States. It lists 17 device types. The FDA files 67 510(k) clearances and 2 PMA approvals under its listings, the newest dated October 9, 2026. 23 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008853977
- Address
- 47900 Bayside Parkway, Fremont, CA, United States, 94538
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 31, 2011
- Registered through
- 2027
- Brand names listed
- 010 Guidewire with ICE Hydrophilic Coating, AXS Catalyst 5, AXS Catalyst 6, AXS Catalyst Distal Access Catheter, AXS Catalyst Distal Access Catheter (AXS Catalyst 7), AXS Infinity LS Plus Long Sheath, AXS Infinity Plus, AXS Lift Intracranial Base Catheter and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 9, 2026 | K261649 | Excelsior Reach Microcatheter | QJP | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| June 24, 2026 | K261772 | Target Xtra Detachable Coil | HCG | Substantially Equivalent | Stryker Neurovscular | accessdata.fda.gov |
| February 11, 2026 | K253032 | AXS Lift Intracranial Base Catheter | QJP | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| December 11, 2025 | K252694 | Target Detachable Coil | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| October 17, 2025 | K251832 | InZone IST Detachment System; IZDS Connecting Cable | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| September 8, 2025 | K250960 | DUO Microcatheter | QJP | Substantially Equivalent | Rev Neuro, LLC | accessdata.fda.gov |
| March 21, 2025 | K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter | QJP | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| February 18, 2025 | K243593 | AXS Lift Intracranial Base Catheter | QJP | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| December 19, 2024 | K241768 | Broadway 8 Catheter | QJP | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| December 19, 2024 | K241637 | Echo Intracranial Base Catheter | QJP | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| August 29, 2024 | K242243 | Target Detachable Coils | HCG | Substantially Equivalent | Stryker Neurovscular | accessdata.fda.gov |
| March 29, 2023 | K223305 | Trevo NXT ProVue Retriever | POL | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| December 14, 2022 | K222533 | Target Tetra Detachable Coils | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| November 26, 2021 | K211594 | Trevo Trak 21 Microcatheter | QJP | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| November 16, 2021 | K212455 | InZone Detachment System | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| August 27, 2021 | K210502 | Trevo NXT ProVue Retriever | POL | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| August 27, 2021 | K202752 | AXS Vecta 46 Intermediate Catheter | QJP | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| December 29, 2020 | K203219 | Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever | POL | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| September 25, 2020 | K202522 | Synchro SELECT Guidewire | MOF | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| February 27, 2020 | K200206 | AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter | QJP | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| February 7, 2020 | K200117 | Trevo NXT ProVue Retriever | POL | Substantially Equivalent | Stryker | accessdata.fda.gov |
| December 15, 2019 | K190833 | AXS Vecta Aspiration Catheter | DQY | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| November 29, 2019 | K193034 | AXS Infinity LS Plus Long Sheath | DQY | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| November 22, 2019 | K192207 | Trevo NXT ProVue Retriever | POL | Substantially Equivalent | Stryker | accessdata.fda.gov |
| November 22, 2019 | K192122 | Trevo Trak 21 Microcatheter | DQO | Substantially Equivalent | Stryker | accessdata.fda.gov |
| August 2, 2019 | K190338 | 046 Zenith Flex | NRY | Substantially Equivalent | Inneuroco, Inc. | accessdata.fda.gov |
| July 30, 2019 | K191768 | AXS Vecta Aspiration System | NRY | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| May 1, 2019 | K190843 | Synchro2 Support Guidewire | MOF | Substantially Equivalent | Stryker | accessdata.fda.gov |
| April 24, 2019 | K190212 | AXS Vecta Aspiration System | NRY | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| March 13, 2019 | K183464 | AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) | NRY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| March 13, 2019 | K183463 | AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm | DQY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| October 25, 2018 | K181354 | 074 Zenith Flex System | NRY | Substantially Equivalent | Inneuroco, Inc. | accessdata.fda.gov |
| April 19, 2018 | K172167 | Zenith Flex System | NRY | Substantially Equivalent | Inneuroco, Inc. | accessdata.fda.gov |
| March 18, 2018 | K173841 | AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm | NRY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| December 6, 2017 | K172468 | 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm | DQY | Substantially Equivalent | Inneuroco, Inc. | accessdata.fda.gov |
| July 28, 2017 | K163259 | AXS Offset Delivery Assist Catheter | DQY | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| June 22, 2016 | K161429 | Target Detachable Coils | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| May 19, 2016 | K153658 | Target Detachable Coils | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| February 19, 2016 | K160096 | InZone Detachment System | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| January 27, 2016 | K153729 | 8F FlowGate2 Balloon Guide Catheter | DQY | Substantially Equivalent | Concentric Medical | accessdata.fda.gov |
| January 8, 2016 | K152876 | LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM | DQY | Substantially Equivalent | Tni Manufacturing, Inc. | accessdata.fda.gov |
| November 13, 2015 | K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm | DQY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| June 12, 2015 | K150616 | Trevo XP ProVue Retriever (4x30mm) | NRY | Substantially Equivalent | Concentric Medical, Inc. | accessdata.fda.gov |
| April 6, 2015 | K143077 | Trevo XP ProVue Retriever (6X25mm) | NRY | Substantially Equivalent | Concentric Medical, Inc. | accessdata.fda.gov |
| November 14, 2014 | K142565 | Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter | DQY | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| February 25, 2014 | K133177 | MODIFIED HD GUIDE CATHETER | DQY | Substantially Equivalent | Concentric Medical, Inc. | accessdata.fda.gov |
| January 13, 2014 | K132641 | MODIFIED TREVO PROVUE RETRIEVER | NRY | Substantially Equivalent | Concentric Medical, Inc. | accessdata.fda.gov |
| January 11, 2013 | K122576 | TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT | MJN | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| November 30, 2012 | K123377 | TARGET DETACHABLE COIL | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| April 20, 2012 | K113778 | EXCELSIOR XT-27 MICROCATHETER | DQY | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| April 17, 2012 | K120816 | INZONE DETACHMENT SYSTEM | KRD | Substantially Equivalent | Stryker | accessdata.fda.gov |
| March 15, 2012 | K112404 | CONCENTRIC BALLOON GUIDE CATHETER | DQY | Substantially Equivalent | Concentric Medical, Inc. | accessdata.fda.gov |
| March 9, 2012 | K113260 | MODIFIED CONCENTIRC MICROCATHETER | DQO | Substantially Equivalent | Concentric Medical, Inc. | accessdata.fda.gov |
| September 30, 2009 | K092666 | INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 | HCG | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| March 13, 2006 | K053268 | PVS 2000 SYNCHRO2 GUIDEWIRE | DQX | Substantially Equivalent | Boston Scientific - Precision Vascular | accessdata.fda.gov |
| October 15, 2004 | K042568 | EXCELSIOR 1018 AND SL-10 MICROCATHETERS | DQY | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| December 4, 2002 | K023700 | PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE | DQX | Substantially Equivalent | Precision Vascular Systems, Inc. | accessdata.fda.gov |
| October 16, 2002 | K022357 | TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 | DQX | Substantially Equivalent | Boston Scientific, Target | accessdata.fda.gov |
| December 6, 2001 | K013789 | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 | DQY | Substantially Equivalent | Boston Scientific, Target | accessdata.fda.gov |
| April 18, 2001 | K010853 | GUIDER SOFTIP GUIDING CATHETER XF 5F | DQY | Substantially Equivalent | Boston Scientific, Target | accessdata.fda.gov |
| March 8, 2001 | K002907 | PVS 1300 NEURO GUIDE WIRE | DQX | Substantially Equivalent | Precision Vascular Systems, Inc. | accessdata.fda.gov |
| August 3, 2000 | K994155 | EXCELSIOR 1018 MICROCATHETER | KRA | Substantially Equivalent | Boston Scientific, Target | accessdata.fda.gov |
| April 7, 2000 | K000177 | RENEGADE HI-FLO MICROCATHETER | KRA | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| November 19, 1997 | K973645 | RENEGADE FIBER BRAIDED MICROCATHETER | KRA | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| July 1, 1997 | K971254 | TRANSEND EX PLATINUM GUIDEWIRE | DQX | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| January 28, 1997 | K964611 | TRANSEND GUIDEWIRE | DQX | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| October 7, 1993 | K934122 | SCIMED TRANSEND EX STEERABLE GUIDE WIRE AND ACCESSORIES | DQX | Substantially Equivalent | Scimed Peripheral Interventions | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 16, 2019 | P180031 | Neuroform Atlas® Stent System | QCA | 12 | October 24, 2026 | accessdata.fda.gov |
| July 13, 2018 | P170024 | Surpass Streamline Flow Diverter | OUT | 26 | August 28, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 6, 2026 | 98630 | Class II | Ongoing | INZONE DETACHMENT SYSTEM, REF: M00345100950 | Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique. | accessdata.fda.gov |
| August 30, 2024 | 95314 | Class II | Ongoing | The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating o | Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US. | accessdata.fda.gov |
| April 23, 2024 | 94437 | Class II | Ongoing | Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog: 90185 Trevo XP ProVue Retriever 6 x 25, Catalog: 90186 Kits: TREVO XP 3X20+PRO1 | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis. | accessdata.fda.gov |
| April 18, 2024 | 94543 | Class II | Ongoing | The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.014in. The guidewires | Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variati | accessdata.fda.gov |
| April 3, 2024 | 94347 | Class II | Ongoing | The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce | Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results. | accessdata.fda.gov |
| June 3, 2022 | 90482 | Class II | Ongoing | Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413; TREVO NXT 4X41+TRAK21 2-PACK - CE, REF: 91414; TREVO NXT 6X37+TRAK21 2-PACK - CE, REF | Microcatheter product label on the carton is missing the microcatheter product drawing/illustration. | accessdata.fda.gov |
| September 21, 2020 | 86583 | Class I | Terminated | Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010 | Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature. | accessdata.fda.gov |
| April 18, 2019 | 82755 | Class II | Terminated | Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO ): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-90, 90cm Product Usage: Indicat | A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft. | accessdata.fda.gov |
| April 10, 2019 | 84780 | Class II | Terminated | Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01) | The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser hoop or during catheter use. | accessdata.fda.gov |
| November 13, 2018 | 83735 | Class II | Terminated | Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771 | Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging | accessdata.fda.gov |
| June 8, 2018 | 81108 | Class II | Terminated | Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and periphe | The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error. | accessdata.fda.gov |
| June 5, 2018 | 80204 | Class II | Terminated | Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, | Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported | accessdata.fda.gov |
| May 2, 2018 | 80652 | Class II | Terminated | AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) | The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded. | accessdata.fda.gov |
| April 11, 2018 | 80353 | Class II | Terminated | FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size) | There may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specification at a customer location. If the user experiences resistance between the FlowGate and an interfacing device, the device would be removed and a second device would be used, which could potentially prolong a procedure. | accessdata.fda.gov |
| November 28, 2017 | 78716 | Class II | Terminated | Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter | Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack. | accessdata.fda.gov |
| November 3, 2017 | 78607 | Class II | Terminated | Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Strok | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack. | accessdata.fda.gov |
| June 26, 2017 | 77671 | Class II | Terminated | Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001 | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack. | accessdata.fda.gov |
| October 5, 2016 | 75447 | Class II | Terminated | Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascul | Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product. | accessdata.fda.gov |
| June 6, 2016 | 74425 | Class II | Terminated | Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascul | Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching. | accessdata.fda.gov |
| March 21, 2016 | 73705 | Class II | Terminated | GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that because of their morphology, th | The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils. | accessdata.fda.gov |
| October 22, 2014 | 69669 | Class II | Terminated | GDC-10 360 SOFT 3mm x 6cm SR; GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are co | Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date. | accessdata.fda.gov |
| November 4, 2013 | 66888 | Class II | Terminated | Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsi | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015. | accessdata.fda.gov |
| June 24, 2013 | 65654 | Class II | Terminated | Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed b | The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. The Model Number on the outer box states UPN M003E345020 (4.5mm x 20 mm Neuroform 3 Stent) while the pouch label states UPN M003E3450300 (4.5mm x 30 mm Neuroform 3 Stent). | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Neurovascular Embolization
- All makers of Device, Vascular, For Promoting Embolization
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- All makers of Catheter, Percutaneous, Neurovasculature
- All makers of Catheter, Thrombus Retriever
- All makers of Guide, Wire, Catheter, Neurovasculature
Updated October 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.