“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
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
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.
Product Description
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.
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.
Product Description
Boston Scientific brand Matrix2 Helical Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
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.
Product Description
Boston Scientific brand Matrix 2D Soft SR Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
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.
Product Description
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.
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.
Product Description
Boston Scientific brand Matrix2 Firm 2D Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.