Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Lotus TAVR 27mm Recalled by Boston Scientific Corporation Due to Lotus valve became unlocked during release from the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected Products
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.
Quantity: 278 units - total all sizes
Why Was This Recalled?
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.
Where Was This Sold?
Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report