Reported Jan 21, 2015 · Terminated
Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number…
Boston Scientific Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 160 Knowles Dr · Los Gatos, CA · 95032-1828
Is this the product you have?
- Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270, Catalog Number LTV27
- Product UsageThe 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
- Lot codes and dates
- Serial numbers
1407603014076031140790121407901314149023141490311414903814149040141500281415002914153080141530811415308214154040141570241415702514157026141570271415702914157030141570311415703214157033141650411416504214165043141650441417503914175040141750411417504214175043141750441417504514175047141780191417802014198066141980671419806814198069. Expiry Datres Nov. 152014 to Jan. 242015
- Serial numbers
- Amount recalled
- 278 units - total all sizes
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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