Drug recall
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number…
FDA recall event 69931 · Class I · Boston Scientific Corporation
Key facts
| Event ID | 69931 |
|---|---|
| Recall numbers | Z-0915-2015, Z-0916-2015, Z-0917-2015 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | 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…, 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…, 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 19, 2014 |
| Report date | Jan 21, 2015 |
| Termination date | Mar 26, 2015 |
| City | Los Gatos |
| State | CA |
| Country | United States |
| FEI number | 3003882783 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: