Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
This recall has been terminated (originally issued November 2, 2016).
- Company
- Stryker Neurovascular
- Recall Initiated
- October 5, 2016
- Posted
- November 2, 2016
- Terminated
- March 23, 2017
- Recall Number
- Z-0336-2017
- Quantity
- 1478 devices, all models and lot numbers
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Lots: 18716056 , 18752458, 18752804. Expiration 12/31/18.
Root Cause
Employee error
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.