CLASS II Device recall · Reported 9 Nov 2016 · FDA Enforcement Report

Guider Softip XF recalled by Stryker Neurovascular

Stryker Neurovascular is recalling Guider Softip XF, distributed nationwide in the US. The recall was initiated on 5 Oct 2016 and the FDA has classified it as Class II.

Check your package

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

Quantity recalled1478 devices, all models and lot numbers.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0341-2017
FDA event ID: 75447
Recalling firm: Stryker Neurovascular, Fremont, CA
Classification: Class II
Status: Terminated
Recall initiated: 5 Oct 2016
FDA classified: 2 Nov 2016
Reported: 9 Nov 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Heart & Vascular Devices

Timeline

5 Oct 2016	Recall initiated by company
2 Nov 2016	Classified by FDA	+28 days
9 Nov 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - US including AK, IL, OH and Internationally to: ARGENTINA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHILE CZECH REPUBLIC ECUADOR EGYPT FRANCE GERMANY GREECE HUNGARY INDIA IRAN ISRAEL ITALIA JAPAN MEXICO NETHERLANDS NORWAY PERU PHILIPPINES POLAND RUSSIA SERBIA SINGAPORE SLOVAKIA SOUTH AFRICA SOUTH KOREA SPAIN SWEDEN SWITZERLAND THAILAND TUNISIA TURKEY UK URUGUAY VIETNAM.

Nationwide Alaska Illinois Ohio

Questions about this recall

Is Guider Softip XF recalled?

Yes. Stryker Neurovascular recalled Guider Softip XF on 5 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-0341-2017.

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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