FDA-Device2016-11-09Class II
Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Stryker Neurovascular
Hazard
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.
Sold states
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.
Affected count
1478 devices, all models and lot numbers.
Manufactured in
47900 Bayside Pkwy, Fremont, CA, United States
Products
Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0342-2017Don't want to check this manually?
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