Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile ...
FDA Recall #Z-0917-2015 — Class I — November 19, 2014
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.
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.
Recalling Firm
Boston Scientific Corporation — Los Gatos, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
278 units - total all sizes
Distribution
Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
Code Information
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.