Z-0335-2017Class II

Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston Scientific Guider...

Name: Z-0335-2017 Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston Scientific Guider...
Creator: Stryker Neurovascular
Published: 2016-10-05
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2016-10-05 / Terminated / root cause: manufacturing process

FDA source

Stryker Neurovascular began a recall of Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate... on 2016-10-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0335-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-05
Posted: 2016-11-02
Terminated: 2017-03-23
Recalling firm: Stryker Corp.
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.
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Stryker Neurovascular sent an Urgent Medical Device Voluntary Recall letter dated October 5, 2016, to all affected customers by Federal Express. Letters advised of the reason for recall and models and devices affected and requested that all affected devices in inventory be returned to Stryker. Customers were advised to circulate the Field Safety Notice internally to all interested/affected parties and to complete the attached customer response form and return the form to their nominated Stryker Representative or to [email protected]. For questions regarding this recall call 510-413-2106.
Quantity in commerce: 1478 devices, all models and lot numbers.
Distribution: 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.
Product codes and lots: Lots 18713978, 18714267,18716054. Expiration 12/31/2018. Lots 18786405, 18786441, Expiration date -1/31/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0335-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0333-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0334-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0335-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0336-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0337-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0338-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0339-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0340-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0341-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0342-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0343-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0344-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0345-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0346-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02
Z-0347-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-09	2016-11-02

Product code DQY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)