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Stryker Neurovascular Recalls
109 recalls on record · July 31, 2013 to July 1, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 8, 2018Medical DevicesFDA
Stryker Neurovascular recalls FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Hazard: 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.
January 24, 2018Medical DevicesFDA
Stryker Neurovascular recalls Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
Hazard: 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.
December 27, 2017Medical DevicesFDA
Stryker Neurovascular recalls Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT,
Hazard: 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.
December 27, 2017Medical DevicesFDA
Stryker Neurovascular recalls Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCA
Hazard: 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.
December 27, 2017Medical DevicesFDA
Stryker Neurovascular recalls Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,1
Hazard: 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.
August 9, 2017Medical DevicesFDA
Stryker Neurovascular recalls Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M
Hazard: 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.
August 9, 2017Medical DevicesFDA
Stryker Neurovascular recalls Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0
Hazard: 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.
August 9, 2017Medical DevicesFDA
Stryker Neurovascular recalls Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0
Hazard: 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.
August 9, 2017Medical DevicesFDA
Stryker Neurovascular recalls Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M003
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiology: Boston Scientific Guider Softip XF Gu
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Cardiology: Boston Scientific Guider Softip
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. Cardiology: Boston Scientific Guider Soft
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiology: Boston Scientific Guider Softip XF Gu
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Cardiology: Boston Scientific Guider Softip X
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology: Boston Scientific Guider Sof
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardiology: Boston Scientific Guider Softip XF
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Soft
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF G
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Cardiology: Boston Scientific Guider Softip
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardiology: Boston Scientific Guider Softip XF
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston Scientific Guider Softip XF
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Cardiology: Boston Scientific Guider Softip X
Hazard: 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.
November 9, 2016Medical DevicesFDA
Stryker Neurovascular recalls Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip
Hazard: 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.
July 20, 2016Medical DevicesFDA
Stryker Neurovascular recalls Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M0035453080 Neurology: Target Detachable Coil
Hazard: 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.
July 20, 2016Medical DevicesFDA
Stryker Neurovascular recalls Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M0035453060 Neurology: Target Detachable Coil
Hazard: 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.
July 20, 2016Medical DevicesFDA
Stryker Neurovascular recalls Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035453040 Neurology: Target Detachable Coil
Hazard: 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.
July 20, 2016Medical DevicesFDA
Stryker Neurovascular recalls Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M0035452560 Neurology: Target Detachable Coils
Hazard: 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.
July 20, 2016Medical DevicesFDA
Stryker Neurovascular recalls Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035452540 Neurology: Target Detachable Co
Hazard: 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.
July 20, 2016Medical DevicesFDA
Stryker Neurovascular recalls Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035452530 Neurology: Target Detachable Co
Hazard: 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.