Stryker Neurovascular: 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.

Agency Publication Date: November 2, 2016

Affected Products

Product: 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 neurovascular system.

Lots 18709130, 18709234, 18709643, 18774858, 18775292; Expiration 12/31/2019. Lots 18785727, 18785933, 18849986; Expiration 01/31/2019.

Product: Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

Lot 18713574. Expiration 11/30/18. Lot s18849984, 18848795. Expiration 01/31/19.

Lot Numbers:

18713574

s18849984

Product: Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

Lots 18713978, 18714267,18716054. Expiration 12/31/2018. Lots 18786405, 18786441, Expiration date -1/31/2019

Product: Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

Lots: 18716056 , 18752458, 18752804. Expiration 12/31/18.

Product: Guider Softip XF; GUIDER/ST XF/8FR/90CM, Model number: H965100520. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

Lot 18725364, Expiration 12/31/18. Lot 18904600, Expiration 02/28/2019.

Lot Numbers:

18725364

18904600

Product: Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

Lot s: 18725976, 18726252, 18726453. Expiration 12/31/18. Lot: 18771999, Expiration 01/31/2019. Lot 19022528, Expiration 03/31/2019.

Lot Numbers:

18771999

19022528

Product: Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

Lot 18753510; Expiration 12/31/18. Lot 18847876, Expiration 01/31/2019.

Lot Numbers:

18753510

18847876

Product: Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

Lot s 18771332, 18771915; Expiration 12/31/18. Lot s18903165, 18928715; Expiration 01/31/2019.

Lot Numbers:

s18903165

Product: Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

Lots 18775812, 18775993 ; Expiration 01/31/19. Lot 18904219, Expiration 02/28/2019; Lots 19025649, 19025651. Expiration 03/31/2019.

Lot Numbers:

18904219

Product: Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

Lot 18786335, 18790229, 18790450. Expiration 12/31/2018. Lot 18851082. Expiration 1/31/2019.

Lot Numbers:

18786335

18851082

Product: Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

Lots 18829078, 18831032, 18831033. Expiration 1/31/2019.

Product: Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

Lots 18845284, 18845814. Expiration 1/31/2019.

Product: Guider Softip XF; GUIDER STRAIGHT XF 5F 90CM, Model number: . M003100640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

Lot 18846232. Expiration 1/31/2019.

Lot Numbers:

18846232

Product: Guider Softip XF; GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

Lot 18903166, Expiration .2/28/2019

Lot Numbers:

18903166

Product: Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.

Lots 18932470, 18932472. Expiration .2/28/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75447

Status: Resolved

Manufacturer: Stryker Neurovascular

Manufactured In: United States

Units Affected: 15 products (1478 devices, all models and lot numbers.; 1478 devices total, all model numbers and lots.; 1478 devices, all models and lot numbers.; 1478 devices, all models and lot numbers; 1478 devices, all models and lot numbers.; 1478 devices, all models and lot numbers.; 1478 devices, all models and lot numbers; 1478 devices, all models and lot numbers; 1478 devices, all models and lot numbers.; 1478 devices, all models and lot numbers.; 1478 devices, all models and lot numbers.; 1478 devices, all models and lot numbers.; 1478 devices, all models and lot numbers; 1478 devices, all models and lot numbers.; 1478 devices, all models and lot numbers.)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lots 18709130, 18709234, 18709643, 18774858, 18775292; Expiration 12/31/2019. Lots 18785727, 18785933, 18849986; Expiration 01/31/2019.

Lot 18713574. Expiration 11/30/18. Lot s18849984, 18848795. Expiration 01/31/19.

Lot Numbers:

18713574

s18849984

Lots 18713978, 18714267,18716054. Expiration 12/31/2018. Lots 18786405, 18786441, Expiration date -1/31/2019

Lots: 18716056 , 18752458, 18752804. Expiration 12/31/18.

Lot 18725364, Expiration 12/31/18. Lot 18904600, Expiration 02/28/2019.

Lot Numbers:

18725364

18904600

Lot s: 18725976, 18726252, 18726453. Expiration 12/31/18. Lot: 18771999, Expiration 01/31/2019. Lot 19022528, Expiration 03/31/2019.

Lot Numbers:

18771999

19022528

Lot 18753510; Expiration 12/31/18. Lot 18847876, Expiration 01/31/2019.

Lot Numbers:

18753510

18847876

Lot s 18771332, 18771915; Expiration 12/31/18. Lot s18903165, 18928715; Expiration 01/31/2019.

Lot Numbers:

s18903165

Lots 18775812, 18775993 ; Expiration 01/31/19. Lot 18904219, Expiration 02/28/2019; Lots 19025649, 19025651. Expiration 03/31/2019.

Lot Numbers:

18904219

Lot 18786335, 18790229, 18790450. Expiration 12/31/2018. Lot 18851082. Expiration 1/31/2019.

Lot Numbers:

18786335

18851082

Lots 18829078, 18831032, 18831033. Expiration 1/31/2019.

Lots 18845284, 18845814. Expiration 1/31/2019.

Lot 18846232. Expiration 1/31/2019.

Lot Numbers:

18846232

Lot 18903166, Expiration .2/28/2019

Lot Numbers:

18903166

Lots 18932470, 18932472. Expiration .2/28/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75447

Status: Resolved

Manufacturer: Stryker Neurovascular

Manufactured In: United States