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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Boston Scientific Corporation
- Reason for Recall:
- Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize and it may be necessary to convert the patient to surgery.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0916-2015
Related Recalls
Model Number L211 PROPONENT DR SL MRI Pacemaker
Boston Scientific
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Model Number S702, ALTRUA 2 DR SL Pacemaker
Boston Scientific
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Model Number U128, VALITUDE CRT-P EL MRI
Boston Scientific
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).