Devices

Boston Scientific Equalizer Balloon Catheter

  • Model / Serial
    Lot: 12156055, 12186592, 12186593, 12186594, 12186596, 12186599, 12227670, 12227671, 12274315, 12303573, 12322322, 12330756, 12330757, 12331003, 12331005, 12331006, 12331007, 12331008, 12368967, 12379423, 12383688, 12397162, 12442599, 12442640, 12442780, 12459665, 12459666, 12526737, 12535281, 12535282, 12535283, 12535284, 12582188, 12605774, 12617283, 12687684, 12702148, 12702149, 12702553.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Washington D.C. and Puerto Rico. Worldwide distribution includes: Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates.
  • Product Description
    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “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.”
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

Boston Scientific Equalizer Balloon Catheter
  • Model / Serial
    Lot: 11637077, 11676784, 11740302, 11811184, 11864634, 11889228, 11960754, 12043982, 12156054, 12170193, 12240685, 12240686, 12311172, 12363749, 12397168, 12397177, 12442594, 12442595, 12490333, 12512652, 12530896, 12535289, 12535290, 12556163, 12567338, 12567339, 12582186, 12603422, 12605776, 12652788, 12652791, 12720339.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Washington D.C. and Puerto Rico. Worldwide distribution includes: Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates.
  • Product Description
    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
  • Manufacturer
    Boston Scientific Corporation
Boston Scientific Equalizer Balloon Catheter
  • Model / Serial
    Lot: 11624018, 11624019, 11638187, 11643049, 11643050, 11657067, 11686940, 11712547, 11721526, 11735828, 11740301, 11747702, 11750848, 11785940, 11788316, 11788317, 11803308, 11803309, 11825804, 11825805, 11875441, 11880429, 11884123, 11889229, 11889231, 11892721, 11902172, 11955040, 11960757, 11973983, 11975227, 11975228, 11981135, 11981137, 11992147, 11996765, 12065122, 12065123, 12084934, 12133497, 12133645, 12147787, 12163202, 12163203, 12189809, 12189810, 12189811, 12195813, 12195814, 12215330, 12227668, 12277652, 12280627, 12293199, 12293420, 12293421, 12315905, 12315906, 12315907, 12325752, 12329910, 12347602, 12347604, 12363753, 12397167, 12424299, 12442596, 12459664, 12490330, 12490331, 12494202, 12523132, 12523133, 12523134, 12530895, 12535287, 12535288, 12546340, 12546341, 12546342, 12556161, 12556162, 12567441, 12567442, 12577711, 12577712, 12577713, 12582627, 12617288, 12617289, 12617290, 12622441, 12622442, 12625396, 12625397, 12702153, 12709943, 12709944, 12709945, 12714571, 12720334.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Washington D.C. and Puerto Rico. Worldwide distribution includes: Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates.
  • Product Description
    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
  • Manufacturer
    Boston Scientific Corporation
Boston Scientific Equalizer Balloon Catheter
  • Model / Serial
    Lot: 11612503, 11613167, 11649850, 11664333, 11675647, 11679806, 11687184, 11703304, 11703305, 11706256, 11706257, 11721527, 11747701, 11748426, 11748427, 11753300, 11818319, 11822020, 11822021, 11823536, 11823537, 11838168, 11872757, 11880388, 11892722, 11894939, 11895181, 11895182, 11905798, 11942328, 11960758, 11973985, 11975229, 11975230, 11981138, 11981139, 11984930, 11992156, 11996764, 12003798, 12003799, 12060855, 12060857, 12065124, 12133643, 12140443, 12143888, 12143890, 12147789, 12159640, 12167057, 12183330, 12185881, 12215326, 12215327, 12227669, 12235732, 12235733, 12235734, 12280629, 12299197, 12299198, 12299199, 12303046, 12303579, 12307240, 12319312, 12319313, 12319314, 12351534, 12351536, 12397165, 12397166, 12400869, 12400870, 12400871, 12419731, 12423640, 12424849, 12424850, 12424851, 12432156, 12438763, 12438764, 12438765, 12438766, 12438767, 12442597, 12535285, 12535286, 12582189, 12582625, 12590510, 12598481, 12598482, 12598483, 12598484, 12617284, 12617285, 12625391, 12625392, 12625393, 12636765, 12636766, 12640395, 12640396, 12640397, 12640398, 12640399, 12685132, 12709946, 12709947.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Washington D.C. and Puerto Rico. Worldwide distribution includes: Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates.
  • Product Description
    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
  • Manufacturer
    Boston Scientific Corporation