Recall archive
25 recalls · page 1 of 2
Reported Jul 1, 2026
INZONE DETACHMENT SYSTEM, REF: M00345100950
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand — Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint…
FDA (openFDA device enforcement)
Reported Oct 16, 2024
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand · Reason for recall — Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and…
FDA (openFDA device enforcement)
Reported Jun 12, 2024
The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand · Product details · Reason for recall — Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand · Reason for recall — Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance…
7 more products in this recall
FDA (openFDA device enforcement)
Reported May 8, 2024
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand · Reason for recall — Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is:…
FDA (openFDA device enforcement)
Reported Feb 21, 2024
Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker, Inc.
Matched: Brand · Product · Product details — The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
Matched: Reason for recall — Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted…
15 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2022
Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand — Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.
FDA (openFDA device enforcement)
Reported Oct 28, 2020
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Stryker Neurovascular
Matched: Brand — Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent…
FDA (openFDA device enforcement)
Reported Apr 8, 2020
Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand · Product · Product details — The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2019
Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO -…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand · Product details — The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension.…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2019
Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand · Product · Product details — Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging
FDA (openFDA device enforcement)
Reported Jun 12, 2019
Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand · Product · Product details — A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.
FDA (openFDA device enforcement)
Reported Oct 10, 2018
AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand — The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
FDA (openFDA device enforcement)
Reported Sep 19, 2018
Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand — Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
FDA (openFDA device enforcement)
Reported Aug 8, 2018
FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand — There may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specification at a customer location. If the…
FDA (openFDA device enforcement)
Reported Jan 24, 2018
Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand · Reason for recall — Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the…
FDA (openFDA device enforcement)
Reported Dec 27, 2017
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand · Reason for recall — Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 9, 2017
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand · Reason for recall — Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 9, 2016
Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand · Product details — Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the…
14 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 20, 2016
Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 Neurology: Target Detachable Coils are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand · Product details · Reason for recall — Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the…
27 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 27, 2016
GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand — The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 10, 2014
GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand — Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2013
Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900; Product is manufactured by Stryker…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
Matched: Brand · Product · Product details — Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration…
18 more products in this recall
FDA (openFDA device enforcement)
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