| Class 1 Device Recall Lotus Valve System | |
Date Initiated by Firm | November 19, 2014 |
Date Posted | January 13, 2015 |
Recall Status1 |
Terminated 3 on March 26, 2015 |
Recall Number | Z-0917-2015 |
Recall Event ID |
69931 |
Product Classification |
Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
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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. |
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 Contact | Brent 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 |
Action | Boston 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 Commerce | 278 units - total all sizes |
Distribution | Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland. |
Total Product Life Cycle | TPLC Device Report |
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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.
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