Stryker Neurovascular: Medical Device Recall in 2016 - (Recall #: Z-0338-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 5, 2016

Date Posted: November 9, 2016

Recall Number: Z-0338-2017

Event ID: 75447

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.

Status: Terminated

Product Quantity: 1478 devices, all models and lot numbers.

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated