Guider Softip XF; GUIDER MPXF 5F 90CM, Model number: M003100630. Cardiology: Boston Scientific Guider Softip XF Guide Ca

FDA device recall Z-0344-2017 · posted 2016-11-02 · Terminated

Recall details

Recalling firm

Stryker Neurovascular

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.

Action taken

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 NVFieldActions@stryker.com. For questions regarding this recall call 510-413-2106.

Root cause

Employee error

Status

Terminated

Product code

DQY

Quantity affected

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 I

Date initiated

2016-10-05

Date posted

2016-11-02

Date terminated

2017-03-23

Location

Fremont, CA

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