FDA Device recall Z-0917-2015
Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
- FDA Device
- Class I
- terminated
- Published 2015-01-21
On 2015-01-21 the FDA classified a Class I recall of Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System by Boston Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0917-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-11-19 |
| Published | 2015-01-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
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
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.
Identifiers
| code_info | Serial numbers: 14076030, 14076031, 14079012, 14079013, 14149023, 14149031, 14149038, 14149040, 14150028, 14150029, 14…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 history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0917-2015%22
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