Recall Z-0338-2017— Stryker Neurovascular

Name: FDA recall Z-0338-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-05

Class II · Terminated

Class II FDA medical device recall by Stryker Neurovascular, initiated 2016-10-05, terminated 2017-03-23. It names 2 FDA 510(k) clearances: K010853, K980453. 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.. Reason: 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..

Recalling firm: Stryker Neurovascular
Classification: Class II
Status: Terminated
Initiated: 2016-10-05
Terminated: 2017-03-23
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K010853 — GUIDER SOFTIP GUIDING CATHETER XF 5FBoston Scientific, Target·cleared 2001-04-18
K980453 — SCHNEIDER GUIDER SOFTIP GUIDING CATHETERSBoston Scientific Scimed, Inc.·cleared 1998-08-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.