Stryker Neurovascular

Complete recall history across all FDA and CPSC categories — 108 total recalls

Stryker Neurovascular appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (108)

FDA medical device enforcement actions by Stryker Neurovascular. Showing most recent 50.

Date Product Reason Class
Aug 30, 2024 The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable st... Stryker Neurovascular has observed that devices with Out of United States (OU... Class II
Apr 23, 2024 Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Cata... Neurovascular devices did not meet the minimum sample size required for endot... Class II
Apr 23, 2024 FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495 Neurovascular devices did not meet the minimum sample size required for endot... Class II
Apr 23, 2024 Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3... Neurovascular devices did not meet the minimum sample size required for endot... Class II
Apr 23, 2024 Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2... Neurovascular devices did not meet the minimum sample size required for endot... Class II
Apr 23, 2024 DAC 044 115cm, Catalog: 90760 Neurovascular devices did not meet the minimum sample size required for endot... Class II
Apr 23, 2024 Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wi... Neurovascular devices did not meet the minimum sample size required for endot... Class II
Apr 23, 2024 Trevo Trak 21 Microcatheter, Catalog: 90338 Neurovascular devices did not meet the minimum sample size required for endot... Class II
Apr 23, 2024 Trevo ProVue, Catalog: 90184 Neurovascular devices did not meet the minimum sample size required for endot... Class II
Apr 18, 2024 The Synchro Neuro Guidewires are a steerable guidewire family with a shapeabl... Stryker Neurovascular has observed an increased frequency of PTFE coating dam... Class II
Apr 18, 2024 The Synchro SELECT Guidewires are a steerable guidewire family with a shapeab... Stryker Neurovascular has observed an increased frequency of PTFE coating dam... Class II
Apr 18, 2024 The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip... Stryker Neurovascular has observed an increased frequency of PTFE coating dam... Class II
Apr 3, 2024 The Distal Access Catheter is a single-lumen, braided shaft, variable stiffne... Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 13... Class II
Jun 3, 2022 Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE... Microcatheter product label on the carton is missing the microcatheter produc... Class II
Sep 21, 2020 Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM... Increase in fracture complaints of the flexible, tapered core wire, resulting... Class I
Apr 18, 2019 Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO,... A design related issue can contribute to the device exhibiting brittle behavi... Class II
Apr 10, 2019 Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC... The firm has become aware of a potential problem that their Catheters may bre... Class II
Apr 10, 2019 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC... The firm has become aware of a potential problem that their Catheters may bre... Class II
Nov 13, 2018 Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE ... Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Ballo... Class II
Jun 8, 2018 Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coatin... The product labels (pouch and carton) for products contain an incorrect value... Class II
Jun 8, 2018 Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Produ... Class II
Jun 8, 2018 Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coa... The product labels (pouch and carton) for products contain an incorrect value... Class II
Jun 8, 2018 Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Pro... The product labels (pouch and carton) for products contain an incorrect value... Class II
Jun 8, 2018 Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coat... The product labels (pouch and carton) for products contain an incorrect value... Class II
Jun 8, 2018 Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Pr... The product labels (pouch and carton) for products contain an incorrect value... Class II
Jun 8, 2018 Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coatin... The product labels (pouch and carton) for products contain an incorrect value... Class II
Jun 8, 2018 Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Prod... The product labels (pouch and carton) for products contain an incorrect value... Class II
Jun 5, 2018 Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0... Use-related coating damage on delivery catheter shafts of Wingspan delivery c... Class II
May 2, 2018 AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x... The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification wa... Class II
Apr 11, 2018 FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm... There may be product manufactured with the outer diameter of the balloon cath... Class II
Nov 28, 2017 Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm an... Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue ... Class II
Nov 3, 2017 Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 m... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and... Class II
Nov 3, 2017 Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 m... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and... Class II
Nov 3, 2017 Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 m... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and... Class II
Jun 26, 2017 Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs wer... Class II
Jun 26, 2017 Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcath... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs wer... Class II
Jun 26, 2017 Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microca... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs wer... Class II
Jun 26, 2017 Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microca... Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs wer... Class II
Oct 5, 2016 Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Ca... Firm became aware of potentially defective Guider Guide Catheters due to a ma... Class II
Oct 5, 2016 Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Car... Firm became aware of potentially defective Guider Guide Catheters due to a ma... Class II
Oct 5, 2016 Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardio... Firm became aware of potentially defective Guider Guide Catheters due to a ma... Class II
Oct 5, 2016 Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiolo... Firm became aware of potentially defective Guider Guide Catheters due to a ma... Class II
Oct 5, 2016 Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. ... Firm became aware of potentially defective Guider Guide Catheters due to a ma... Class II
Oct 5, 2016 Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiolo... Firm became aware of potentially defective Guider Guide Catheters due to a ma... Class II
Oct 5, 2016 Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardio... Firm became aware of potentially defective Guider Guide Catheters due to a ma... Class II
Oct 5, 2016 Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . ... Firm became aware of potentially defective Guider Guide Catheters due to a ma... Class II
Oct 5, 2016 Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Card... Firm became aware of potentially defective Guider Guide Catheters due to a ma... Class II
Oct 5, 2016 Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiol... Firm became aware of potentially defective Guider Guide Catheters due to a ma... Class II
Oct 5, 2016 Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardio... Firm became aware of potentially defective Guider Guide Catheters due to a ma... Class II
Oct 5, 2016 Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardio... Firm became aware of potentially defective Guider Guide Catheters due to a ma... Class II

View all 108 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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