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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific brand Matrix 3D Omega Standard Coils

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  Class 2 Device Recall Boston Scientific brand Matrix 3D Omega Standard Coils see related information
Date Initiated by Firm October 19, 2010
Date Posted January 05, 2011
Recall Status1 Terminated 3 on January 27, 2012
Recall Number Z-0857-2011
Recall Event ID 57179
510(K)Number K031168  K012985  
Product Classification Clamp, Uterine - Product Code HGC
Product Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
Code Information Material Product Description Catalog # Batch Numbers Expiry Date   M0034751030 Matrix2¿ 3D-Omega Standard 475103 13097570 Oct2012   Coils 1 Omm x 30cm  M0034753060 Matrix2¿ 3D-Omega Standard 475306 13204826 Dec2012   Coils 3mm x 6cm  M0034754060 Matrix2¿ 3D-Omega Standard 475406 13199749 Dec2012   Coils 4mm x 6cm  M0034755080 Matrix2¿ 3D-Omega Standard 475508 13204829 Dec2012   Coils 5mm x 8cm  M0034755100 Matrix2¿ 3D-Omega Standard 475510 13097571 Oct2012   Coils 5mm x 10cm
Recalling Firm/
Manufacturer		 Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538
47900 Bayside Pkwy
Fremont CA 94538-6515
For Additional Information Contact Robert Ware
510-624-2544
Manufacturer Reason
for Recall		 The product appears to have premature degradation of the PGLA coating on the Matrix Coil.
FDA Determined
Cause 2		 Process control
Action US consignees were notified by letter sent by Federal Express on October 19, 2010. Customers out of the United States were notified by Federal Express if possible and by personal delivery by locally assigned sales representatives as needed.
Quantity in Commerce 77,364 total units
Distribution Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HGC and Original Applicant = BOSTON SCIENTIFIC, TARGET
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