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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- 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 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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0915-2015
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