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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific brand Matrix2 2D Standard SR Coils.

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  Class 2 Device Recall Boston Scientific brand Matrix2 2D Standard SR 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-0854-2011
Recall Event ID 57179
510(K)Number K031168  K012985  
Product Classification vascular embolization device - Product Code HGC
Product Boston Scientific brand Matrix2 2D Standard SR 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¿ 2D Standard SR Coils 11286278,11535148,11975068,11975079, Oct2010 through  M003470103SRO 470103-SR 11985922,12156355,12156606,12176009,   10mm x30cm 12330517,12356322,12392934,13602979 Jun2013  M003470308SRO Matrix2¿ 2D Standard SR Coils 470308-SR 11766418,11775113 May2011 through   3mm x8cm May2011   Matrix2¿ 2D Standard SR Coils 11423155,11766419,11836539,11963593, Dec2010 through  M003470410SRO 470410-SR 12156359,12176012,12260125,12358023,   4mm x 10cm 12792923, 13705207 Jul2013  M003470510SRO Matrix2¿ 2D Standard SR Coils 470510-SR 12246984 Nov2011   5mmx10cm   Matrix2¿ 2D Standard SR Coils 11344392,11697463,11873433,11967353, Nov2010 through  M003470515SRO 470515-SR 12156357, 12156624, 12176010, 12259384,   5mmx15cm 12368756,12469532 Feb2012  M003470610SRO Matrix2¿ 2D Standard SR Coils 470610-SR 11800373,12520967 May2011 through   6mmx10cm Mar2012  M003470615SRO Matrix2¿ 2D Standard SR Coils 470615-SR 11377053,11985920,13201010,13220262 Dec2010 through   6mmx15cm Dec2012   Matrix2¿ 20 Standard SR Coils 11414852,11869799,11925610,11967354, Dec2010 through  M003470620SRO 470620-SR 12156352,12156602,12156627,12176016,   6mm x20cm 12261954, 12359026, 13015863, 13115971 Nov2012  M003470715SRO Matrix2¿ 2D Standard SR Coils 470715-SR 11622085,12379812,12853030 Mar2011 through   7mm x 15cm Jul2012  M003470720SRO Matrix2¿ 2D Standard SR Coils 470720-SR 11800378,11984852,13201011,13220457 May2011 through   7mm x20cm Oec2012   Matrix2¿ 2D Standard SR Coils 11869790,11925609,11940380,11992208, Jun2011 through  .J1003470730SRO 470730-SR 12156353,12156605,12176081,12176125,   7mm x30cm 12261953,12311506 Dec2011  M003470820SRO Matrix2¿ 2D Standard SR Coils 470820-SR 11248568,11946183,13201012 Oct2010 through   8mm x20cm Dec2012   Matrix2¿ 2D Standard SR Coils 11552555, 11925611, 11940382, 11975162, Feb2011 through  M003470830SRO 470830-SR 12176014,12261957,12316891,12361241,   8mm x 30cm 12401291 Jan2012  M003470920SRO Matrix2¿ 2D Standard SR Coils 470920-SR 13602873   9mm x20cm Jun2013   Matrix2¿ 2D Standard SR Coils 11869791, 11925176, 11975070, 11975185, Jun2011 through  M003470930SRO 470930-SR 12156358,12156615,12176011,12261956,   9mm x30cm 12370630 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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