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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific brand Matrix2 360 Firm Coils.

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  Class 2 Device Recall Boston Scientific brand Matrix2 360 Firm 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-0861-2011
Recall Event ID 57179
510(K)Number K031168  K012985  
Product Classification vascular embolization device - Product Code HGC
Product Boston Scientific brand Matrix2 360 Firm 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    Matrix2¿ 360 Firm Coils 1 Omm x 11252548,11403351,11513899,11552537, Oct2010 through  M0034941 030 494103 11640881,12009568,12102561,12229607,   30cm 12365838, 12366382 Jan2012  M0034941230 Matrix2¿ 360 Firm Coils 12mm x 494123 11560338,11766417,11782395,11925586, Feb2011 through   30cm 12026743, 12316656, 12636596 Apr2012   11244766,11336915,11456769,11484774,  M0034941430 Matrix2¿ 360 Firm Coils 14mm x 494143 11526777, 11766660, 11850791, 11958233, Oct2010 through   30cm 11958454,12317003,12396265,12753164, Jan2013   13165081,13182077,13230095   11253266,11336717,11454608,11489048,  M0034941630 Matrix2¿ 360 Firm Coils 16mm x 494163 11526778,11697444,11697471,11958444, Oct2010 through   30cm 12176133,12214864,12319343,12396264, Dec2012   12859706, 13194482   11385269,11389724,11454839,11498643,  M0034941 830 Matrix2¿ 360 Firm Coils 18mm x 494183 11609723,11766661,11869780,11958440, Dec2010 through   30cm 12036898,12225706,12316657,12365837, Aug2012   12396263, 12854017, 12929266   Matrix2¿ 360 Firm Coils 20mm x 11330476,11483884,11526779,11697442, Nov2010 through  M0034942030 494203 11766414,11766673,11958234,11999799,   30cm 12194742,12317006,12753163,12859707 Jul2012   11252232,11380482,11551322,11785187,   11785188,11785190,11785191,11785192,  M0034942440 Matrix2¿ 360 Firm Coils 24mm x 494244 11785193,11785194,11785195,11813607, Oct2010 through   40cm 11813608,11813609,11813610,11850841, Jul2012   12176108,12316654,12395388,12395420,   12428559,12429040,12841941,12861721  M0034945150 Matrix2¿ 360 Firm Coils 5mm x 494515 12214867,12636725 Oct2011 through   15cm Apr2012  M00349461 50 Matrix2¿ 360 Firm Coils 6mm x 494615 11340651,11474492,11958445 Nov2010 through   15cm Jul2011  M0034947200 Matrix2¿ 360 Firm Coils 7mm x 494720 11338767,11697459 Nov2010 through   20cm Apr2011  M0034948300 Matrix2¿ 360 Firm Coils 8mm x 494830 11488191,11850853,12000340 Jan2011 through   30cm Aug2011  M0034949300 Matrix2¿ 360 Firm Coils 9mm x 494930 11327025,11697448,11838298,11958230, Nov2010 through   30cm 12365839,12367860 Jan2012    
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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