Devices

Device Recall Lotus Valve System

  • Model / Serial
    Serial numbers: 14076030, 14076031, 14079012, 14079013, 14149023, 14149031, 14149038, 14149040, 14150028, 14150029, 14153080, 14153081, 14153082, 14154040, 14157024, 14157025, 14157026, 14157027, 14157029, 14157030, 14157031, 14157032, 14157033, 14165041, 14165042, 14165043, 14165044, 14175039, 14175040, 14175041, 14175042, 14175043, 14175044, 14175045, 14175047, 14178019, 14178020, 14198066, 14198067, 14198068, 14198069. Expiry Datres Nov. 15, 2014 to Jan. 24, 2015.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
  • Product Description
    Lotus TAVR 27mm, || Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; || Sterile || Material number H749LTV270, Catalog Number LTV27; || Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.
  • Manufacturer
    Boston Scientific Corporation
  • 1 Event

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 160 Knowles Dr, Los Gatos CA 95032-1828
  • 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

2 devices with a similar name

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Device Recall Lotus Valve System
  • Model / Serial
    Serial numbers: 14113043, 14118011, 14118012, 14119047, 14119048, 14119049, 14119050, 14119051, 14120027, 14120028, 14120029, 14120030, 14120031, 14121035, 14121036, 14121037, 14121038, 14121039, 14121040, 14121041, 14125040, 14125041, 14125042, 14125043, 14125044, 14125045, 14125046, 14125047, 14125048, 14125049, 14127073, 14127077, 14127078, 14127079, 14127080, 14127081, 14127082, 14127083, 14127084, 14127085, 14127086, 14141044, 14141045, 14141046, 14141047, 14141048, 14141049, 14141050, 14141051, 14141052, 14141053, 14148034, 14148035, 14148036, 14148037, 14148039, 14153054, 14153055, 14153057, 14153058, 14153059, 14153075, 14153076, 14153077, 14153078, 14153079, 14157003, 14157015, 14157016, 14157017, 14157019, 14157020, 14157021, 14157022, 14157023, 14178024, 14178025, 14178026, 14178027, 14178028. Nov. 15, 2014 to Jan. 24, 2015.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
  • Product Description
    Lotus TAVR 23mm, || Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; || Sterile || Material number H749LTV230, Catalog Number LTV23; || Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.
  • Manufacturer
    Boston Scientific Corporation
Device Recall Lotus Valve System
  • Model / Serial
    Serial numbers: 14126051, 14126052, 14126053, 14127058, 14128047, 14128048, 14128049, 14128050, 14129004, 14129005, 14129006, 14129007, 14129008, 14133006, 14133007, 14133008, 14133009, 14133010, 14134042, 14134043, 14134044, 14134045, 14134047, 14134049, 14134050, 14134054, 14148005, 14148006, 14148007, 14148008, 14148009, 14148010, 14148011, 14148012, 14148013, 14148014, 14148015, 14148019, 14148020, 14148021, 14148022, 14148023, 14148024, 14148026, 14148027, 14156025, 14156026, 14157007, 14157008, 14157009, 14157010, 14157011, 14157012, 14157013, 14160009, 14160011, 14160012, 14160015, 14161036, 14161037, 14161038, 14161040, 14162050, 14162051, 14162053, 14162054, 14163052, 14163053, 14163054, 14163055, 14165004, 14165005, 14165006, 14165007, 14165008, 14167012, 14167013, 14167015, 14167016, 14167017, 14167018, 14167019, 14167020, 14167021, 14170001, 14170002, 14170003, 14170004, 14170005, 14170031, 14170032, 14170034, 14170035, 14170036, 14170037, 14170038, 14170039, 14170040, 14171031, 14171032, 14171033, 14171036, 14171037, 14171038, 14171039, 14171040, 14172017, 14172018, 14172019, 14172020, 14172021, 14172022, 14172023, 14172024, 14176021, 14176022, 14176023, 14176024, 14176025, 14176029, 14176030, 14176031, 14176032, 14176033, 14178036, 14178038, 14178039, 14178040, 14178041, 14178042, 14178043, 14178045, 14179048, 14179050, 14179051, 14179052, 14179053, 14179054, 14179055, 14179057, 14182027, 14182029, 14182031, 14183011, 14183013, 14183014, 14183015, 14184003, 14184004, 14184005, 14184006, 14184007, 14184008, 14184009, 14184010, 14184011, 14188009, 14188010, 14188012, 14188013, 14188014, 14188015, 14188016, 14188017, 14188018, 14191021, 14191022, 14191023, 14191024, 14191030, 14193002, 14193003, 14193007, 14193011, 14193012, 14193013, 14193014, 14193022, 14197042, 14197047, 14197048, 14197049. Expiry Datres Nov. 15, 2014 to Jan. 24, 2015.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
  • Product Description
    Lotus TAVR 25mm, || Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; || Sterile || Material number H749LTV250, Catalog Number LTV25; || Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.
  • Manufacturer
    Boston Scientific Corporation