• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Lotus Valve System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall Lotus Valve Systemsee related information
Date Initiated by FirmNovember 19, 2014
Date PostedJanuary 13, 2015
Recall Status1 Terminated 3 on March 26, 2015
Recall NumberZ-0917-2015
Recall Event ID 69931
Product Classification Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
ProductLotus 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.
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.
Recalling Firm/
Manufacturer
Boston Scientific Corporation
160 Knowles Dr
Los Gatos CA 95032-1828
For Additional Information ContactBrent Hathcoak
763-494-1133
Manufacturer 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.
FDA Determined
Cause 2
Device Design
ActionBoston Scientific notified consignees on November 19, 2014, of the problem via letter through overnight delivery directing consignees to segregate and return affected product to Boston Scientific utilizing the Field Safety Corrective Action (FSCA) Instructions provided. The FSCA details that consignees should: Immediately discontinue use of and segregate product; Complete and return the Account Reply Verification Tracking form and Package/Ship the affected product.
Quantity in Commerce278 units - total all sizes
DistributionDistributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-